(Senior) Specialist Regulatory Affairs (f/m) in Selzach at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

Job Description

Your key responsibilities

  • For the first 2 years you will work in a dedicated, cross functional and energetic project team implementing the EU MDR requirements in the Trauma & Extremities Division
  • In your new role as Senior RA Specialist you organize and implement strategies and activities required to procure regulatory approval for new and revised product lines.
  • You ensure compliance to all US, EU and international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products.
  • You apply scientific principles to understanding safety and efficacy on a wide range of products.
  • You interface and coordinate with the FDA, Notified Bodies and other regulatory agencies on submissions, approvals or other issues.
  • You support R&D, marketing and manufacturing teams in regulatory assessment of proposed changes or product transfers.
  • Moreover, you participate in cross functional team activities from initial stages through securing government approvals for any initiative and project requiring Regulatory Affairs support.


What are we looking for?

  • You have a Bachelor’s Degree in a scientific discipline. Ideally, you dispose of a RAC certification.
  • You have a minimum of 2-3 years’ experience in a highly regulated industry and you have working knowledge of Medical Device Regulations (FDA/MDD required, additional international a plus).
  • You have gained experience with 510(k), EU MDD 93/42/EEC Technical File/Design Dossier preparation.
  • You have successfully interacted with FDA and notified body reviewers/inspectors and you have a sound understanding of scientific principles.
  • You are fluent in English and have ideally a good knowledge of German.


Contact

If you have questions regarding the advertised position, please do not hesitate to contact Mrs. Nicole Röll by phone on +49 (0) 4348 702 685. Please notice that the title of this advertisement can differ from the position title.

Work From Home: No

Travel Percentage: None

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