Regulatory Affairs Position – EU Regulatory Affairs in Gurugram at Stryker Corporation

Date Posted: 6/27/2018

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Job Description


As a contributor to the regulatory affairs team, you will support the execution of the project plan to ensure ongoing compliance to the upcoming EU Medical Device Regulations. Specifically, you will be assigned various regulatory activities including but not limited to: review and update to Technical Files and/or Design Dossiers, gap assessment for current files under EU Medical Device Directive to EU Medical Device Regulations, and/or input into product labeling or procedure revisions to demonstrate compliance. The individual will be working with various work stream leads to identify gaps, develop strategy on closing the gaps, and help execute against the strategy.


•       Bachelor’s Degree in Engineering or Biological/Life Sciences required,

•       Minimum of 2 years’ experience with medical devices sold in the EU, strong working knowledge of EU regulations including experience with developing and preparing submissions for EU Notified Bodies (Technical Files and Design Dossiers)

•       Experience with orthopedic devices is preferred

•       Prior experience collaborating in cross-functional development teams providing feedback as the RA representative

•       Prior experience working on new EU Medical Device Regulation implementation projects and/or large enterprise projects desired


Work From Home: No

Travel Percentage: None

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