Regulatory Affairs, Project Manager

  • Salary: Competitive
  • REF Number: 00051932
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 800 106 106
  • Date Published: 04.11.2021
  • Sector: Medical Devices
  • Location: Zuchwil, Central Switzerland
  • Discipline: Clinical - Regulatory Affairs

Jocelyn Blackham is recruiting for a Regulatory Affairs Project Manager to join a leading Medical Device company at their site based in Zuchwil on a contract basis for 12 months, with the possibility of extension.

The main purpose of the role willbe to:

  • Support MDR compliance execution work by acting as project manager who has oversight on ongoing MDR compliance work for and drives completion of MDR deliverables
  • Coordinate and drive resolving of NB questions to submitted Technical Documentation
  • Lead regular status update meetings with corresponding teams who are working on individual MDR files and/ or specific topics

Further responsibilities will include:

  • Facilitating resolving of roadblocks and timeline constraints
  • Leading and tracking cross-functional activities as assigned, such as MDR Indication definition and Technical Documentation submissions to Notified Body

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

  • Project Management experience within Medical Device industry
  • Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)
  • Fluent in English is essential, German would be a nice to have.

This is an excellent opportunity to join a leading Medical Device company.

For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or emailjblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 51932 in all correspondence.uimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference QLS 00051978 in all correspondence.all correspondence.

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