Description
We have new opportunity for a senior Regulatory Affairs expert, to support assigned projects within a medical devices area and compliance with new regulations globally.Position duties and responsibilities:
Support execution of project plans for MDR compliance Lead and track completion of MDR compliance activities and Technical documentation Files according to set plans Lead regular meetings with corresponding teams to discuss projects deliverable and targets Provide updates on MDR compliance progress for assigned projects and governance team. Support implementation of the documents in PLM systems and ensure correct sequences of approvals. Lead and track cross-functional activities as assigned, such implementation and Technical Documentation submissions to Notified Body Provide project management support for business activities needed in preparation for MDR compliance as instructed and assigned.
Candidate requirements:
experience in Project Management in Technical File remediation activities understanding of MDR requirements and content of Technical Documentation understanding of current Council Directive 93/42/EEC Solid experience MS Office, especially in MS Project Strong analytical skills and proficiency in English written and spoken.
This is 12 months contract role in Switzerland, extension may be possible.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.