project manager - regulatory affairs in medical devices in Solothurn

Lucie Nasshan, Basel Professionals Health Care & Life Sciences
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job details

Life Sciences
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lucie nasshan, basel professionals health care & life sciences
058 201 55 50
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job description

Randstad Professionals is currently looking for a Project Manager - Regulatory Affairs  in Medical Devices who will be assigned an interesting challenge for a major client based in Solothurn.

This contract is a great opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start ASAP ( december 2018) and will last until December 2019.

Your role will be to support MDR compliance execution work by acting as project manager who has oversight on ongoing MDR compliance work for Trauma/CMF/BIO and drives completion of MDR deliverables.


  • Support execution of project plan for MDR compliance in Trauma/CMF/BIO business for 2019.

  • Lead and track completion of MDR compliance activities for multiple given Technical documentation Files according to project plan

  • Lead regular status update meetings with corresponding teams who are working on individual MDR files

  • Provide regular status updates on MDR compliance progress for Trauma/CMF/BIO to MDR PMO and governance team.

  • Facilitate resolving of roadblocks and timeline constraints for individual MDR files

  • Support for routing and implementation of the remediated documents in PLM systems and ensure correct sequences of approvals.

  • Lead and track cross-functional activities as assigned, such as MDR IFU implementation and Technical Documentation submissions to Notified Body

  • Provide project management support for base business activities needed in preparation for MDR compliance as instructed and assigned.

Candidates’s profile :

  • At least 2 years Project Management experience with preference of previous project management experience in Technical File remediation activities

  • Basic understanding of MDR requirements regarding required content of Technical Documentation

  • Basic understanding of current Council Directive 93/42/EEC

  • Previous experience with Notified Body interactions (e.g. renewals of Class III products)preferred

  • Experienced skills in MS Office, especially in MS Project

  • Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.