Project Manager - Regulatory Affairs

Posted 18 October 2021
SalaryNegotiable
LocationZuchwil
Job type Limited
DisciplineLife Sciences
ReferenceBBBH487655_1634553476

Job description

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

Job description:

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.

Tasks

  • 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.

Professional background

  • 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

Workplace: Zuchwil

Workload: 100%

Start Date: 01.11.2021

Duration: 14 months

Your Application

Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Judith Atgé Martin (+41 61 270 80 16).