Lediga job som Medicinsk ingenjör

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.

Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.

Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.

We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.

You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.

This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.

• Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)

• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs

• Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements

• Collaborate closely with R&D on design changes and process improvements

• Support and continuously improve our ISO 13485-certified QMS

• Support regulatory submissions and updates (EU MDR, FDA)

• Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes

• Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness

• Work cross-functionally with product, regulatory, and operations teams

You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.

• Very strong technical project management skills

• Strong technical experience with active medical devices

• Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)

• Hands-on experience with supplier and manufacturing quality control

• Proven experience managing Technical Files / DHF / DMR

• Expertise in ISO 13485 QMS implementation and maintenance

• Experience with FDA regulations (QMSR) and EU MDR

• Experience with FDA inspections and/or Notified Body audits

• Experience with FDA PMA devices (Class III) and PMA supplements

• Background in combination hardware/software medical devices

• Quality management system automation, eQMS & AI-tools.

• Experience working closely with Asia-based contract manufacturers

• Experience working with neurotech.

• You take ownership and operate with high autonomy

• You’re structured, detail-oriented, and pragmatic

• You can translate regulatory requirements into efficient processes

• You enjoy working cross-functionally with engineers and operators

• You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing

• Work on a clinically proven treatment for one of the world’s largest health problems

• Be part of a company transitioning into global scale (including the US market)

• Own meaningful parts of the quality and regulatory backbone of a US Class III device

• Join a mission-driven team combining science, engineering, and real-world impact

Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

Job description

MedTech Specialist - Consultant Opportunities

Join Our Team at Randstad Life Sciences

Randstad Life Sciences is looking for experienced and motivated MedTech professionals for future consultant assignments in the Gothenburg area.

At Randstad Life Sciences, we are dedicated to helping you advance your career and achieve your goals. As a consultant with us, you will enjoy competitive compensation, valuable benefits, and the security of collective agreements. Your dedicated consultant manager will guide you throughout your journey, connecting you with diverse, rewarding assignments across leading life sciences organizations. Through our vast professional network, ongoing learning opportunities, and personalized support, we empower you to continuously grow and make an impact in your field.

Please note that this is an open, proactive posting for future assignments. While scope and duration vary by client, typical engagements last approximately 6 months. We seek professionals across all levels of seniority to contribute to critical projects, ranging from R&D and laboratory work to quality assurance and clinical research. You will collaborate in cross-functional teams and with internal and external stakeholders. You are expected to follow strict and detailed regulatory standards and maintain precise documentation. You are a science-driven professional with a proactive mindset. You excel both independently and in team settings, demonstrating flexibility, curiosity, and a strong sense of responsibility. You are adept at building relationships and navigating complex stakeholder landscapes.

At Randstad Life Sciences, we focus on specialized expertise as part of Randstad, a global leader in talent solutions dedicated to becoming the world's most equitable and focused talent organization. Based in the Netherlands, Randstad spans 39 markets with roughly 40,000 employees worldwide. By combining our expansive global reach with strong local connections, we deliver rewarding opportunities for academics and specialists. As your dedicated talent partner, we empower you to advance your career, acquire key skills, and thrive in a meaningful professional environment. At Randstad Life Science, we are committed to equity and diversity. We value individuality and welcome applications from all qualified candidates.

Deadline: 2026-10-18, selection process and interviews will be ongoing, so please apply as soon as possible. For questions, please contact Klara Danielsson

Please note: Applications sent via email will not be processed and will be deleted in accordance with GDPR compliance. 

Responsibilities

• Contribute to the development, testing, and quality assurance of medical devices and processes, adhering to strict regulatory standards and directives
• Maintain precise documentation in compliance with both company protocols and global regulatory requirements
• Collaborate effectively with internal and external stakeholders to drive project success
• Engage proactively in technical and cross-functional teams to build and maintain professional networks

Qualifications

• MSc or engineering degree Medical Technology, Biotechnology, Chemistry, Pharmacy, or a closely related, relevant field
• 5-8 years documented professional experience within a medical technology company, specifically in the development, manufacture, or research of medical devices or services
• High level of attention to detail and accuracy
• Proficient in both English and Swedish (written and verbal)

About the company

Randstad