Regulatory Affairs Specialist in Freiburg im Breisgau at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

Job Description

Regulatory Affairs Specialist

Main contributor for the implementation of the new EU MDR requirements in the area of Regulatory Affairs- Instruments Navigation:

Your key responsibilities

  • Organize & perform the creation of the 2017/745 EU MDR Annex II Technical Documentation (Class I – Class III) for the Navigation Portfolio & Pipeline.
  • Organize & perform the creation of the 2017/745 EU MDR Annex I GSPR Checklist for the Navigation Portfolio & Pipeline.
  • Help the cross-functional EU MDR project team with identifying potential gaps and define strategies for effective gap closures in the area of Technical Documentation and GSPR.
  • Drive improvements & efficiency of the Annex II Technical Documentation creation in an electronic document management system.
  • Support updates of necessary SOP’s and templates under EU MDR for the area of Regulatory Affairs and adjacent departments.
  • Support of the initial EU MDR Notified Body Audit and Technical Documentation sampling.
  • Help with regular Technical File maintenance under 93/42 EEC and change management activities.

What are we looking for?

  • Min. 2 years’ experience in a Regulatory or Quality role for a Medical Device Manufacturer.
  • Degree in Life Sciences, Engineering or equivalent.
  • Profound knowledge of 93/42 EEC and Technical Files/ Design Dossiers.
  • Ideally already basic 2017/745 EU MDR knowledge.
  • Enjoys working in a regulated environment (FDA, ISO 13485, …)
  • Hands-on mentality & comfortable in making decisions.
  • Job requires an understanding and application of procedures and concepts of own discipline. 
  • The job requires the ability to make judgements based on practice and previous experience. 

    Work From Home: No

    Travel Percentage: None

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