Risk Management/Regulatory Affairs Specialist
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 email@example.com, quoting job ref 48514.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.