Senior QA/RA Specialist

🇨🇭 Senior Specialist – Quality & Regulatory Affairs | Swiss MedTech

We're partnering with a leading Swiss medical-device manufacture r 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