Risk Management/Regulatory Affairs Specialist

  • Salary: Competitive
  • REF Number: 00048514
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 15.07.2020
  • Sector: Medical Devices
  • Location: Central Switzerland, East Switzerland
  • Discipline: Clinical - Regulatory Affairs

CK QLS are recruiting for a Risk Management/Regulatory Affairs Specialist to join an international medical device company at their site based Graubünden on a permanent basis.

Risk Management/Regulatory Affairs Specialist Role: The main purpose of the role will be to:

  • Assist in the development and implementation of ISO 14971 in the internal risk management process for medical devices throughout their entire life cycle.
  • Complete risk management documentation.
  • Execute GAP analyzes, preparation of defect reports and training in the corresponding changes.
  • Create and update technical documentation, as well as checking the completeness and correctness of project documentation.

Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Qualification in the natural sciences, electrical engineering or medicine or completed vocational training with practical experience and additional professional training (e.g. master craftsman, technician, technical diploma).
  • Knowledge of ISO 14971 and IEC 60601 series.
  • Experience in quality management, development, testing and production of medical devices is an advantage.
  • Professional experience in risk management/regulatory affairs/quality.

This is an excellent opportunity to join an international medical device company.

Apply: For more information or to apply for this Risk Management/Regulatory Affairs Specialist position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 48514.

Please could you send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

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