Regulatory Affairs Project Manager - 12 months contract- Switzerland
The new role has was created for the experienced expert in project management and regulatory affairs to support MDR compliance execution and overseeing on ongoing MDR compliance activities 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.
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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.