Post Market Surveillance Specialist, Medical Devices

Katalyst HealthCares & Life Sciences - Carlsbad, CA (30+ days ago)


Job Description:

  • Individual must ensure that the requirements for post market surveillance reports are met through creating reports.
  • Should obtain data such as Risk Assessments, Clinical Evaluation Reports, Complaints, Vigilance, Medical Device Reports, CAPAs etc. by working with the cross functional teams.
  • Individual must plan, implant and ensure compliance to Medical Devices regulatory programs.
  • Coordinate activities/tasks and resources across affected departments.
  • Responsible for supporting a Regulatory Affairs program.
  • 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.
  • Expert in writing Post Market Surveillance (PMS) Report, Medical devices.
  • Expert in sustaining updated reports through the in-house tracker.

Job Type: Contract

Experience:

  • Medical Devices regulatory programs: 8 years (Preferred)