Quality & Regulatory Affairs Manager - Freelancer

We are looking for a Quality & Regulatory Affairs Manager (freelancer) for a focused, 3-month freelance engagement. The primary objective is the retroactive normalisation and completion of our technical SaMD documentation.

What you need:

• Strong hands-on experience with MedTech / SaMD software documentation, preferably in products preparing for certification.
• Deep practical knowledge of Design Control Systems and QMS requirements for medical software (ISO 13485, FDA software expectations).
• Experience with tools such as Greenlight Guru, Jama, or similar documentation / traceability platforms
• Proven experience with retroactive compliance - organizing, completing, and restructuring documentation created “after the fact.”
• Ability to audit existing product and technical documentation, identify...