Project Manager - Regulatory Affairs

☞ Randstad Switzerland

看过: 151

更新日: 24-04-2024

位置: Solothurn Solothurn SO

类别: 规划/项目 IT-软件

行业: Staffing Recruiting Biotechnology Pharmaceuticals

水平: Entry level

工作类型: Full-time

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工作内容

Do you want to work in a big medical devices company? Do you have experience in Project Management for Medical Devices? You should then read the following lines!

Our client, based in the Solothurn area, is looking for a Project Manager - Regulatory Affairs for a one year contract.

Job Description

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. This activity includes but is not limited to:
  • 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.
What We Need From The Candidate
  • 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).
  • Excellent person interaction skills and reliable and goal oriented work attitude
  • Experienced skills in MS Office, especially in MS Project
  • Strong analytical skills
  • Fluent in English. German in addition, would be an asset.
Do not waste any minutes, apply now! We are looking forward to receiving your application.

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
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最后期限: 08-06-2024

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