Stryker Regulatory Affairs Specialist in Freiburg, Germany
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
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com