Project Manager - Regulatory Affairs - MDR Tech Files
Regulatory Affairs - MDR Tech Files - Project Manager
Leading global medical device client require a Project Manager with relevant Regulatory affairs and MDR experience for a long-term contract in Zucwhil.
- 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:
Support execution of project plan for MDR compliance in Trauma/CMF/BIO business for 2019.
Lead and track completion of MDR compliance activities for multiple given Technical documentation Files according to project plan
Lead regular status update meetings with corresponding teams who are working on individual MDR files
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 for individual MDR files
Support for routing and implementation of the remediated documents in PLM systems and ensure correct sequences of approvals.
Lead and track cross-functional activities as assigned, such as MDR IFU implementation and Technical Documentation submissions to Notified Body
Provide project management support for base business activities needed in preparation for MDR compliance as instructed and assigned.
What we need from the candidate:
* At least 2 years Project Management experience with preference of previous project management experience in Technical File remediation activities.
* Basic understanding of MDR requirements regarding required content of Technical Documentation
* Basic understanding of current Council Directive 93/42/EEC
* Previous experience with Notified Body interactions (eg renewals of Class III products)preferred
* Experienced skills in MS Office, especially in MS Project
* Strong analytical skills and proficiency in English written and spoken.
Please apply now for more details!