Overview
Senior QA/RA Specialist Jobs in Bern-Mittelland, Berne, Switzerland at Europa Group International
Title: Senior QA/RA Specialist
Company: Europa Group International
Location: Bern-Mittelland, Berne, Switzerland
🇨🇭 Senior Specialist – Quality & Regulatory Affairs | Swiss MedTech
We're partnering with a leading Swiss medical-device manufacturer to hire Senior Specialists in Quality & Regulatory Affairs. Bringing broad, hands-on roles for experts who build compliance into life-changing medical devices.
What you could do:
- Lead the creation and maintenance of Technical Documentation across the product lifecycle
- Manage CE marking under MDR (FDA submissions and international registrations an asset)
- Own quality-system activities within an ISO 13485 QMS — CAPA, deviations and change control
- Drive process and equipment validation (IQ/OQ/PQ) and risk management (ISO 14971)
- Lead Post-Market Surveillance, vigilance and market monitoring
- Act as primary liaison with notified bodies and authorities, and support audits
- Partner with R&D, Production, Quality and Clinical to bring compliant products to market
What makes you a great fit:
- Degree in Engineering, Life Sciences or related, with several years in Quality and/or Regulatory Affairs in medical devices
- Strong working knowledge of EU MDR, ISO 13485, technical documentation, validation and risk management
- Fluent in German/French and English
- Structured, proactive and solution-oriented, with strong communication and stakeholder skills
