Regulatory Affairs Specialist EU MDR - 18 months contract in Freiburg im Breisgau at Stryker Corporation

Date Posted: 1/30/2020

Job Snapshot

Job Description

Regulatory Affairs Specialist - EU MDR

In this role you will be the key contributor for the implementation of the new EU MDR requirements in the area of Regulatory Affairs- Instruments AGT in Freiburg. This role is initially a temporary role as parental leave backfill.

Your key responsibilities include:

  • Responsible for creation & maintenance of the EU technical documentation (TD & GSPR Annex I & II, 2017/745 EU MDR) for class I-III devices for Computer Assisted Surgery
  • Responsible for ensuring alignment of strategic EU MDR TD & GSPR approaches between the 3 Stryker sites in the USA, Ireland and Germany
  • Support of Notified Body TD submissions, audits and reviews for EU MDR
  • Creation of Regulatory Affairs Change Management Assessments related to EU MDR in electronic document management system
  • Provide RA support for labeling changes, EU UDI activities, DHF reviews, PMS reports and Clinical Evaluation reviews as part of EU MDR
  • Support daily business activities for the Regulatory Affairs department (e.g. change management, data management)

What are we looking for?

  • Degree in Life Sciences, (Medical-) Engineering or equivalent.
  • Ideally up to 2 years of experience in Manufacturing/Engineering - experience from Regulatory or Quality role for a Medical Device Manufacturer is preferred
  • Knowledge of EU Medical Device Regulation (EU MDR) 2017/745 is a plus
  • Medical device product remediation project experience (for example DHF, Technical Documentation)
  • Computer literacy, proficiency in Office 365 package- e.g. MS Word, Excel, PowerPoint, SharePoint
  • Fluent (written & verbal) in English and German
  • You enjoy working in a regulated environment (FDA, ISO 13485, …)
  • Hands-on mentality & comfortable in making decisions

Work From Home: Occasional

Travel Percentage: 10%

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