Senior Medical Device Quality & Regulatory Engineer

Flow Neuroscience; Malmö kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Flow Neuroscience is expanding its team with a Senior Medical Device Quality & Regulatory Engineer to own critical QA and regulatory infrastructure across the product lifecycle. The role collaborates with R&D, manufacturing, and supply chain to maintain DHFs, DHMs, and regulatory filings.

You will drive ISO 13485 QMS implementation, support EU MDR and FDA submissions, and prepare for inspections across global jurisdictions, in a hybrid setup between Sweden and the UK.

Qualifications

• Strong technical background in medical-device software or hardware/product engineering.
• Hands-on experience in medical-device design, development and manufacturing.
• Excellent ISO 13485 and FDA QMSR knowledge and implementation experience.
• Experience with FDA inspections and Notified Body audits.
• Proven ability to manage Technical Files / DHF / DMR and supplier quality control.

Responsibilities

• Lead and maintain Design Control processes (DHF, verification/validation, risk management, change control).
• Own and maintain Technical Documentation / Technical Files / DHFs / DMRs.
• Drive supplier qualification, auditing, and ongoing manufacturing quality control improvements.
• Collaborate with R&D on design changes and process improvements.
• Support ISO 13485‑certified QMS and regulatory submissions (EU MDR, FDA).
• Ensure compliance with evolving regulations (FDA QMSR, EU/UK MDR).

Skills

Project management

Medical device hardware

Regulatory knowledge

Design controls ISO 13485

FDA QMSR experience

Supplier quality control

Technical Files / DHF / DMR

Regulatory submissions

Audits (FDA/Notified Bodies)

Job description

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
  

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.