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Regulatory Affairs Manager – Medical Devices

Regulatory Affairs Manager – Medical Devices

Contract
Salary: Competitive
Location: Switzerland/France
Category: Medical Devices

Description

We are partnered with a leading medical device company who are looking for a Regulatory Affairs Project Manager to come in for an initial 6 month period to lead a transition MDD -> MDR project. Specific information on the role is available if required.

The role can be located in Eastern France or Western Switzerland. If you’re looking for a new challenge, this will move very quickly with a view to move permanent available.

Key Responsibilities

  • Manage update and maintenance of legacy technical documentation; propose and implement actions following GAP analysis with respect to MDD and MDR
  • Coordinate cross-functional activities regarding technical documentation (i.e. with R&D, Clinical Affairs)
  • Manage project team to update all technical files in the framework of MDR implementation
  • Ensure implementation of all required actions to update technical documentation
  • Prepare and manage product risk management meetings
  • Candidate Requirements

  • Bachelors’ or Masters’ degree in Biomedical Engineering, Life Sciences, or equivalent
  • 5 years’ experience in technical file management in an international MedTech environment
  • Strong background in Risk (EN ISO 14971), Usability Engineering (EN 62366), Biological Safety (ISO 10993-x)
  • Good knowledge of the European MDD and European MDR
  • Fluent English; French or German would be a plus
  • For more info contact: Christopher Collins
    Email Address: christopher.collins@conciliumsearch.com
    Contact Number: +44 207 397 6623