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.

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.