For our client, a franchise of orthopaedic and neurosurgery companies, we are looking for a motivated personality in the function of
Project Manager - Regulatory Affairs
You will support MDR compliance execution work by acting as project manager who has oversight on ongoing MDR compliance work for DePuy Synthes Trauma/CMF/BIO and drives completion of MDR deliverables.
- Coordinate and drive resolving of NB questions to submitted Technical Documentation
- 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
- Support execution of project plan for MDR compliance in Trauma/CMF/BIO business for 2021/ 2022.
- Lead regular status update meetings with corresponding teams who are working on individual MDR files and/ or specific topics
- Lead and track cross-functional activities as assigned, such as MDR Indication definition and Technical Documentation submissions to Notified Body
- Provide project management support for activities needed in preparation for MDR compliance as instructed and assigned.
- At least 2 years 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).
- Previous experience at DePuy Synthes preferred
- Excellent person interaction skills and reliable and goal oriented work attitude
- Experienced skills in MS Office, especially in MS Project
- Strong analytical skills
Fundamental for this role:
- English Fluent, German would be an asset
Start Date: 01.11.2021
Duration: 14 months
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Judith Atgé Martin (+41 61 270 80 16).