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:

• Experience in leading at least one full FDA cycle on a complex medtech product, ideally de Novo or PMA.
• Excellent verbal and written communication skills, able to collaborate with a multidisciplinary team.
• Ability to balance regulatory and quality requirements with the project's size and maturity while ensuring compliance.
• Fast learner, ready to dive into the role with a steep learning curve.
• A passion for contributing to Robeauté's mission and making an impact.

Perks & Benefits:

• Flexible remote work options (part of the week).
• BSPCE (stock options) available.
• Compensation based on experience and profile.

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.