Project Manager - Regulatory Affairs - MDR Tech Files

Sentinel IT LLP
€650 - €700 daily
06 Dec 2018
20 Dec 2018
Professional / Specialist
Contract Type
Contract / Interim

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.

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:

  • 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:

  • Some 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!