Medical writer

• Develop and refine strategies and processes for market and customer feedback collection.
• Assist in creating medical device market research protocols and Case Report Forms.
• Craft and update post-market surveillance plans, Periodic Safety Update Reports, and Post Market Surveillance reports.
• Collaborate with cross-functional teams and surgeons for Post Market Clinical Follow-up studies.
• Keep relevant procedures up-to-date .
• Utilize your knowledge of medical devices and In-Vitro Diagnostic products to gather proactive customer feedback per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746).
• Create market research protocols, deploy questionnaires, and compile technical reports.
• Review and provide feedback on (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports).
• Author and update post-market surveillance plans for upcoming and existing medical devices.
• Interface with engineering, medical, safety, regulatory, quality, and manufacturing teams to complete surveillance activities.
• Ensure timely creation of deliverables to prevent project delays.
• Develop proactive customer feedback templates and process workflows.
• Communicate roadblocks and escalate issues promptly to stakeholders.

Medical Writer

Healthcare Clinical Documentation Integrity Consultant

Senior Medical Writer

Clinical Documentation Integrity Specialist – 2nd Level Reviewer

Principal Medical Writer