Related skills
qms iso 13485 samd ce marking iec 62304📋 Description
- Establish and improve the QMS for SaMD regulatory compliance.
- Manage e-QMS: document control, versioning, traceability.
- Coordinate internal and external audits and regulatory submissions.
- Drive QMS adoption across cross-functional teams via training.
- Lead regulatory documentation to support CE marking and submissions.
- Define process maps and KPI dashboards for quality and risk.
🎯 Requirements
- 4-6 years in SaMD regulatory compliance; CE marking for Class IIa+.
- Deep knowledge of ISO 13485, MDR 2017/745, IEC 62304, IEC 82304.
- Strong analytical thinking, structured problem solving, and PM skills.
- Ability to translate regulatory requirements for non-regulatory teams.
- Fluent in English and French; German or Italian a plus.
- Experience conducting audits and creating regulatory documentation.
🎁 Benefits
- Free health insurance for you and your children.
- Parental Care Program: extra leave on top of legal leave.
- Free mental health and coaching services via Moka.care.
- Relocation support for international mobilities.
- Work from abroad up to 10 days per year (flexibility days).
- Lunch voucher with Swile card.
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