Senior Regulatory Affairs Specialist in Gurugram bei Stryker Corporation

Datum der Veröffentlichung: 5/28/2019

Stellenauszug

Stellenbeschreibung

As a contributor to the regulatory affairs team, you will support the execution of the project plan to ensure ongoing compliance to the upcoming 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, 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 Mechanical/ Manufacturing Engineering
  • Minimum of 3-4 years’ experience with medical devices
  • Strong working knowledge of FDA and EU regulations including experience with developing and preparing submissions for EU Notified Bodies (Technical Files and Design Dossiers)/regulatory authorities
  • Experience with orthopedic devices is preferred
  • Prior experience collaborating in cross-functional development teams providing feedback as the RA representative
  • Prior experience working on Medical Device Regulation implementation projects and/or large enterprise projects desired

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Work From Home: No

Travel Percentage: None

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