Related skills
qms iso 13485 samd ce marking iec 62304📋 Description
- Design and improve the QMS to meet ISO 13485 and MDR 2017/745.
- Ensure safe, compliant SaMD products across the lifecycle.
- Own the e-QMS for document control, versioning, and traceability.
- Lead process risk management with dashboards and KPIs to surface risks.
- Design and deliver cross-functional regulatory training.
- Collaborate across QARA, Tech, Product, Data Science, Legal and Ops to embed compliance.
🎯 Requirements
- Fluent in English and French.
- 4–6 years in SaMD regulatory compliance; CE marking for Class IIa+.
- Deep knowledge of ISO 13485, MDR 2017/745, IEC 62304, IEC 82304.
- Analytical, structured problem-solving and strong PM skills.
- Translate regulatory complexity into actionable guidance.
- Nice-to-haves: e-QMS experience; AI/ML regulatory considerations; German/Italian a plus.
🎁 Benefits
- Free health insurance for you and your children.
- Parental Care Program: extra leave on top of legal leave.
- Free mental health and coaching via Moka.care.
- Work from abroad up to 10 days per year.
- Lunch voucher with Swile card.
- Relocation support for international mobilities.
🚚 Relocation support
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to All Other Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!