MDR Project Manager (Medical Device)

For our client, Switzerland's leading medical device company, we are looking for a Project Manager with experience in the medical device industry and knowledge of MDR regulations. This is initially a 12-month contract, with extension possibility, based in the Solothurn area, Switzerland.

Responsibilities:

You will support the MDR compliance execution as project manager who has oversight on ongoing MDR compliance work for Trauma/CMF/BIO and drive completion of MDR deliverables. This activity includes but is not limited to:

• Coordinating and driving the resolving of NB questions to submitted Technical Documentation
• Providing regular status updates on MDR compliance progress for Trauma/CMF/BIO to MDR PMO and governance team.
• Facilitating resolving of roadblocks and timeline constraints.
• Supporting the execution of project plan for MDR compliance in Trauma/CMF/BIO business for 2021/ 2022.
• Leading regular status update meetings with corresponding teams who are working on individual MDR files and/ or specific topics.
• Leading and tracking cross-functional activities as assigned, such as MDR Indication definition and Technical Documentation submissions to Notified Body.
• Providing project management support for activities needed in preparation for MDR compliance as instructed and assigned.

Must Haves:

• 2+ years Project Management experience within the 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 awork attitude
• Experienced MS Office skills, especially in MS Project
• Strong analytical skills

Nice to haves:

• German

General Information:

Duration: initially 12 months

Extension: possible

Location: Canton Solothurn, Switzerland

Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. Should you have any questions please contact Nastasia Whyte on +41 61 282 22 13.

Even if this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland. Check out all of Experis' job openings at www.experis.ch.