Senior Medical Device Quality & Regulatory Engineer

Senior Medical Device Quality & Regulatory Engineer We’re hiring a Senior Medical Device Quality & Regulatory Engineer at Flow — a hands-on role spanning engineering, manufacturing, QA and regulatory in a fast-growing neurotech company. 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. Department Product Development Locations Malmö, London Remote status Hybrid About Flow Neuroscience Flow Neuroscience’s mission is to develop new ways to combat mental health issues with science and technology. The first product is a medication-free treatment for depression, the leading cause of disability in the world. It combines a brain stimulation wearable and an app-based therapy program to create a new effective, safe, and affordable way to treat depression, at home. Founded in 2016 Applicant tracking system by Teamtailor