Interim Quality & Regulatory Consultant - MedTech (Freelance)

South Germany | Full-time | Freelance / Interim | Medical Devices

We're looking for an experienced Quality & Regulatory Consultant to support a leading MedTech company with QMS remediation and CAPA system improvements during a key regulatory transition phase.

Your Role

Support QMS remediation aligned with EU MDR, ISO 13485, and GxP
Help optimize CAPA and NC management systems
Contribute to audit readiness and inspection preparation
Collaborate with internal teams and suppliers on quality and compliance topics
Provide input on risk management and regulatory documentation

Your Profile

5+ years in Quality Management or Regulatory Affairs in MedTech or Life Sciences
Familiar with QMS transitions, CAPA systems, and audit processes
Knowledge of ISO 13485, ISO 14971, EU MDR, and GMP/GxP
Strong communication skills in German and English
Hands-on, solution-oriented, and comfortable working independently

What We Offer

A meaningful role in a high-impact project
Flexible freelance engagement with autonomy and influence
Opportunity to work with a forward-thinking MedTech team

Interested?

Send your CV or project portfolio to or apply below