REEV | Engineer 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 an Engineer of Quality & Regulatory Affairs to lead our regulatory efforts and quality systems across both continents, starting with the US market.

Your Role

According to REEV’s Quality and Regulatory Affairs strategy, you will help ensure our products comply with applicable international standards and regulations for electromedical devices.

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 62366-1, IEC 62304, IEC 60601-1 and relevant standards.
Analyze regulatory standards applying to products and extract design constraints.
Participate in risk analyses (ISO 14971).
Manage usability studies (IEC 62366-1).
Ensure the product’s electrical safety (IEC 60601-1, 60601-11, etc.).
Coordinate software development in compliance with the standard (IEC 62304).
Manage 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.
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.
5 – 10+ 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.