Regulatory Consultant, Medical Device MDSS

Katalyst HealthCares & Life Sciences - Carlsbad, CA

30+ days agoContract

Job Description:

  • Individual must plan, implant and ensure compliance of the Technical File to the medical device regulation.
  • Must have expertise of registering products with one of the EU authorized representatives.
  • Should have in depth knowledge of both EU MDD and EU MDR.
  • Individual must plan, implant and ensure compliance to Medical Devices regulatory programs.
  • Coordinate activities/tasks and resources across affected departments.
  • Coordinates and manages small to medium scope projects.
  • Work direction is provided and is generally supervised and reviewed by more senior staff.
  • Lead cross-functional teams and Project Management experience is plus.
  • Minimum of 5 Years of Experience.
  • Should be expert in Technical Files of medical devices.
  • Should have experience with Medical Device Safety Service (MDSS - EU Authorized Rep) Registration

Job Type: Contract


  • Medical Device Safety Service: 7 years (Preferred)