Senior Regulatory Affairs and Quality Assurance Engineer

Michael Page

Le Vaud

Responsibilities:
• Manage technical documentation writing (for Europe & the US)
• Participate in the development and design of medical devices
• Handle risk management throughout the device lifecycle
• Review and approve validation and verification documents
• Act as Process Owner
• Contribute to internal & external audits
• Collaborate with cross-functional teams and support QA/RA trainings

Requirements:
• Minimum 3 years of experience in the medical device sector
• Familiarity with ISO 13485, ISO 14971, 21 CFR, MDR
• Experience in preparing technical files for Europe & the US
• Proficiency in French and English More Detail

Apply Now

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