Project Manager - Regulatory Affairs
Ver: 155
Dia de atualização: 25-03-2024
Localização: Solothurn Solothurn SO
Categoria: Planejamento / Projetos IT - Software
Indústria: Staffing Recruiting Biotechnology Pharmaceuticals
Posição: Entry level
Tipo de empregos: Full-time
Conteúdo do emprego
Do you want to work in a big pharmaceutical 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.
- 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.
Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
Data limite: 09-05-2024
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