Senior Medical Device Quality & Regulatory Engineer

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.