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Risk Manager

Risk Manager

EPM ScientificSwitzerland
Il y a plus de 30 jours
Description de poste

EPM is currently partnered with one of the leading Medical Device Manufacturers of intelligent ventilators who is seeking a Risk Manager to join their team

Responsibilities :

  • Planning and implementing the risk management process throughout the entire life cycle of the devices and accessories in accordance with relevant standards.
  • Monitoring compliance with risk management processes and standards, ensuring adherence to internal processes and conducting compliant risk assessments.
  • Serving as the primary point of contact for inquiries related to the risk management process.
  • Providing support for internal and external audits, product approvals, and communication with regulatory authorities and partners.
  • Contributing to the ongoing development and training of the risk management process.

Qualifications :

  • A university degree in engineering or relevant experience in a related technical field.
  • Proficiency with international standards such as ISO 13485 and ISO 14971, as well as familiarity with medical device regulations like MDR 2017 / 745 and 21 CFR 820.
  • Fluency in German and business-level proficiency in English (Level C1).