Startup Offres d'emploi - Bobigny 93

QA / RA Specialist (Experienced) - Health tech startup

Cherry Ventures is supporting our portfolio with this hire

Location : Paris (Robeauté, Cochin)

About the Role :

Join our dynamic and mission-driven team at Robeauté as a QA / RA Expert. You'll be the key contact with regulatory authorities like the FDA and EMA, guiding our medtech innovations through complex regulatory landscapes. You'll lead the design control process for verification and validation (V&V) and ensure our Quality Management System (QMS) is implemented and followed throughout the product development lifecycle. Additionally, you'll supervise regulatory and quality operations at our manufacturing facility, managing FDA visits and audits when needed.

What You'll Do :

• Be the primary liaison with FDA and EMA for regulatory processes.
• Implement and manage design controls to support V&V and coordinate across teams.
• Establish and oversee Robeauté's QMS and ensure compliance throughout design and development.
• Supervise quality and regulatory processes at our manufacturing site.
• Organize FDA visits and manage audits as required.

What You Bring :

Perks & Benefits :

Cherry Ventures is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, or disability status.