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Senior Medical Device Quality & Regulatory Engineer

Flow Neuroscience · Remote (US) · Remote

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About Flow Neuroscience

Flow is now available at home, by prescription. Backed by Khosla and SOSV.

About 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.

What they're looking for

  • 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
More about this role

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,...

Read the full posting on Flow Neuroscience's site ↗

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