Risk Management Specialist

Details

  • Category: Combination products
  • Location: Lausanne area
  • Starting date: Dec 01, 2018
  • Domain of experience: Medical Devices, Risk Management, Regulatory Affairs
  • Level required: Mid-senior level
  • Years of experience: 5+

Your Role

In this role you will be in charge of risk management files remediation with customer experience collected over time.

Your Tasks

  • Collect the inventory of detailed risk assessment and extract relevant inputs from customer complaints and post-market surveillance for 2 different platforms
  • Reconcile the information within the risk management files
  • Coordinate and align remediation activities with Risk Management and Medical Affairs teams
  • Follow up on update planning / execution
  • Support the Global MDR project (managed by the US team) as Risk Management Expert

Your Profile

  •     At least 5 years of experience in risk management of complex medical devices (hardware and software)
  •     Previous experience with post-market surveillance activities is a strong asset
  •     Good understanding of ISO 14971
  •    Strong knowledge of EU MDR 2017/745
  •     Excellent English written and spoken
  •    Autonomous and independent
  •    Good team player with strong communication skills
  • Dec 31, 2018
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