Senior Medical Device Quality & Regulatory Engineer
Flow Neuroscience AB · Malmö · Tills vidare
Flow Neuroscience is hiring a **Senior Medical Device Quality & Regulatory Engineer** to support the global scaling of its neuromodulation treatment for depression. Working in a **hybrid setup** from either Skåne, Sweden, or London, UK—with on-site presence required a few times per week—the role serves as the technical owner across the full product lifecycle. Key responsibilities include leading design control processes, maintaining technical files, device master records, and design history files, and driving supplier quality and manufacturing improvements with contract manufacturers. The position also supports regulatory submissions for EU MDR and the FDA, maintains an ISO 13485-certified quality management system, and ensures audit and inspection readiness. Candidates must have a strong technical background in either medical device software or hardware/product engineering, alongside hands-on experience in medical device design, development, and manufacturing. Strong technical experience with **active medical devices**, robust technical project management skills, and proven expertise with ISO 13485 and FDA QMSR (21 CFR Part 820) are required. Applicants also need hands-on experience managing audits and technical documentation. Valuable assets include experience with FDA PMA Class III devices, neurotechnology, combination hardware/software devices, Asia-based contract manufacturers, and eQMS automation.
Senior Medical Device Quality & Regulatory Engineer
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.
The Role
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.
What You’ll Do
- 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
What We’re Looking For
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.
Core Competencies
- 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
Bonus (Highly Valuable)
- 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.
Who You Are
- 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
Why join us?
- 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.