Stellenbeschreibung
Quality & Regulatory Affairs Specialist | Medical Devices | Remote | Germany
⚠️ NOTE: Professional German is a strict requirement. If you cannot communicate and write documentation fluently in German, please do not apply.
We're looking for a hands-on Quality & Regulatory Affairs Specialist to support a medical technology company on a freelance basis. This isn't a strategy-only seat. You'll be deep in documentation, audit prep, risk management and keeping the QMS running the way it should.
What you'll be doing:
- Create, review, and maintain technical documentation in line with regulatory requirements
- Support audit preparation and participate in internal and external audits
- Contribute to risk management activities (ISO 14971)
- Manage CAPA processes and change control
- Support supplier evaluation and supplier quality activities
- Ensure compliance with ISO 13485 and EU MDR requirements
What we're looking for:
- Hands-on QM or RA experience in medical devices or a similarly regulated industry
- You have personally written and maintained technical files, not just reviewed them
- Audit experience, either preparing or participating
- ISO 14971 risk management knowledge
- Structured, detail-oriented, and compliance-driven
- Professional German and English, both required
Nice to have:
- MDR transition experience
- CAPA and change management background
- Supplier evaluation or control experience
- FDA regulatory knowledge
Job type: Freelance Location: Fully remote Workplace: Germany
If you have worked in medical devices, MedTech, or another regulated industry and you are comfortable with hands-on documentation, audits, risk management and QMS work, we'd be happy to hear from you.
