Regulatory Affairs Specialist II

3 days ago


Leeds, Leeds, United Kingdom CTI Clinical Trial and Consulting Services Full time
Job Overview

The company is recruiting for a Regulatory Affairs Specialist II to support our Sports Orthopedics business. This role will follow a Flex/Hybrid schedule with 3 days per week in the office.

This position provides regulatory guidance to project teams in business planning and related submissions to support DePuy Synthes Arthroscopic Equipment Solutions products. The individual develops and performs regulatory strategies for significant change supplements and 510(k) registrations to support the continued commercialization of products in key countries.

About You
  • You have a Bachelor's Degree in Biomedical Engineering, medical/scientific writing, or other Engineering focus.
  • You have at least 3+ years of regulatory affairs or related/equivalent experience in the Medical Device sector.
  • You possess demonstrated expertise in medical device regulatory requirements and processes.
  • You are skilled in project management and can lead multiple projects simultaneously.


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