Medical Writer/Clinical Specialist - EU-MDR regulations & PMCF plans/report

Full Time
Sylmar, CA
Posted
Job description

This role is specific to EU Medical Device Regulation (MDR) post market clinical follow up (PMCF) planning and reporting. Must feel comfortable collecting, analyzing, and writing up data into reports, as well as planning for future data collections. Will act as Clinical Affair's representative to cross-functional meetings for regulatory submissions. Must be comfortable developing and managing timelines for deliverables and interfacing with cross-functional teams on a a regular basis. Willing to consider candidates onsite as well as remote.

Need candidates who are knowledgeable with EU-MDR regulations and experienced medical writers of regulatory documents like the PMCF plans and reports.

Job Types: Full-time, Contract

Pay: $100.00 - $110.00 per hour

Schedule:

  • 8 hour shift

Ability to commute/relocate:

  • Sylmar, CA: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Bachelor's (Preferred)

Experience:

  • Clinical affairs, Clinical Affair's representative: 5 years (Preferred)
  • Post market clinical follow up (PMCF) planning and reporting: 4 years (Preferred)
  • EU Medical Device Regulation (MDR): 5 years (Preferred)
  • collecting, analyzing, and writing up data into reports: 5 years (Preferred)
  • interfacing with cross-functional teams on a a regular basis: 5 years (Preferred)
  • Medical Writers of regulatory documents like PMCF reports: 5 years (Preferred)

Work Location: In person

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