We are currently looking for a Risk Management Engineer for a temporary assignment within an innovative international company in the medical devices sector, based in Vaud.

Your responsibilities:

• Manage risk management activities throughout the product lifecycle.
• Maintain and update risk management files (RMF) in accordance with regulatory requirements and post-market surveillance.
• Conduct and coordinate risk analyses (Design/Process FMEA, equipment, methods, raw materials, packaging, technical complaints, adverse events).
• Participate in annual reviews and risk assessments related to changes, CAPA, non-conformities, and industrial transfers.
• Collaborate with Development, Quality, Validation, Regulatory, and Production teams to integrate the risk approach across all processes.
• Contribute to regulatory submissions and respond to requests from competent authorities.
• Train and support teams on best practices and risk management standards.
• Participate in internal and external audits and ensure a continuous improvement approach.

Your profile

• Master's degree in engineering, sciences, or equivalent training.
• Minimum 8 years of experience in the pharmaceutical or medical device industry.
• Strong expertise in risk management, quality assurance, validation, and product development.
• Proficiency in applicable standards and regulations: ISO 14971, ISO 13485, MDR 2017/745, GMP, ISO 62366, 21 CFR Part 820 and CAPA/NCR environment.
• Excellent analytical, problem-solving skills and ability to lead cross-functional working groups.
• Fluent in French and English, both written and spoken.
• Autonomy, rigour, and ability to thrive in a demanding and dynamic environment.