REEV | Director of Quality & Regulatory Affairs

About REEV

At REEV, we build intelligent wearable robotics that help people with difficulty walking recover mobility freedom. Our flagship product, DREEVEN, is a robotic knee brace designed to restore mobility for individuals with neuromuscular disorders. With over $12M raised and a transatlantic team operating from France and the US, we’re entering an exciting new phase: obtaining FDA 510(k) clearance and scaling our impact globally.

We’re now hiring a Director of Quality & Regulatory Affairs to lead our regulatory efforts and quality systems across both continents, starting with the US market.

Your Role

You will own and drive REEV’s regulatory and quality strategy, ensuring our products meet international medical device standards — with an immediate focus on leading the FDA 510(k) submission and clearance process for DREEVEN.

Key Responsibilities

Regulatory Affairs

Define and execute the US regulatory strategy for DREEVEN, with a focus on obtaining FDA 510(k) clearance
Own the preparation, submission, and follow-up of the 510(k) dossier
Manage communications with the FDA and other regulatory bodies
Monitor regulatory changes and assess impact on REEV products
Support global market access (EU MDR, Canada, etc.) over time

Quality Assurance

Implement and manage the quality management system (QMS compliance with Medical Device standards: ISO 13485, EU regulation 2017/745, FDA).
Ensure compliance with QSR (21 CFR Part 820), ISO 14971, IEC 62304, and relevant standards.
Analyze regulatory standards applying to products and extract design constraints.
Lead and coordinate risk analyses (ISO 14971).
Lead and coordinate usability studies (IEC 62366-1).
Lead and coordinate safety (IEC 60601-1, 60601-11, etc.).
Lead and coordinate software dev. according to standard (IEC 62304).
Lead internal and external audits, including FDA inspections.
Participate in, lead and coordinate the drafting of CE marking files (Technical Documentation).
Manage exchanges with certification laboratories (COFRAC & CB).
Manage exchanges with Notified Bodies.
Lead PMS.
Champion a culture of quality across teams — from engineering to clinical

Leadership & Collaboration

Report directly to the Co-Founders and work closely with Product, Engineering, Clinical, and Operations
Build and manage a growing QA/RA team over time
Represent REEV with notified bodies, consultants, and regulatory partners

What We’re Looking For

Proven track record in leading a successful FDA 510(k) submission for a Class II medical device.
10–15+ years experience in Regulatory Affairs and Quality in the medical device industry.
Strong knowledge of technical standards to support projects under development ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, IEC 62366-1.
Strong knowledge of FDA QSR.
Experience with robotic, wearable, or electro-mechanical devices is a big plus.
Comfortable working in a startup or scale-up environment.
Excellent written and spoken English (French is a strong bonus).
Based in or willing to relocate to Toulouse, France.