QA-RA Director

A fast-growing medical device startup is seeking an experienced QA/RA Director to lead our transition from development to commercial manufacturing.

Key Responsibilities:

• Lead the QC team, redefine roles, and ensure compliance with ISO 13485 and 21 CFR Part 820.
• Oversee the submission of Technical Files and QMS for EU-MDR certification.
• Establish and maintain a robust Quality Management System.
• Manage regulatory submissions and communications with global regulatory bodies.
• Collaborate with R&D, Operations, and Clinical teams on risk management and compliance.

What We’re Looking For:

• 8+ years of Quality and Regulatory management experience, especially with Class III medical devices.
• Strong leadership and team management skills.
• Hands-on approach with excellent communication.
• Fluent in English.