More jobs:
Global Head of Quality & Regulatory Affairs; QRA)
Job in
3000, Bern, Canton de Berne, Switzerland
Listed on 2026-09-02
Listing for:
RetinAI Medical
Full Time
position Listed on 2026-09-02
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Ikerian AG in Bern, Switzerland, seeks a Head of Quality & Regulatory Affairs to elevate global compliance for SaMD. You will lead a distributed QRA team, drive regulatory strategy, and partner with R&D to integrate design controls and risk management from early development.
The role requires PRRC experience, 10+ years in quality/regulatory leadership, and deep ISO 13485, EU MDR, IEC 62304, ISO 14971, and FDA 21 CFR Part 820 knowledge. CET availability is essential.
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