Clinical Evaluation Medical Writer

Clinical Evaluation Medical Writer (12 month contract // REMOTE, team based in CO) HM's Top Needs:

• Experience in PSUR and PMCF writing in compliance with the European Union Medical Device Regulation (EU MDR), including PMS data analysis and risk–benefit evaluation.
• Strong expertise in clinical literature analysis, including systematic searches, critical appraisal, and clinical data synthesis.
• Solid project management skills with the ability to manage timelines, coordinate stakeholders, and ensure timely deliverables.
• Proficient in Microsoft Office, particularly advanced MS Word (structured formatting, templates, track changes, and document control).

Education Required:

Bachelor’s Degree in Life Sciences, Pharmacy, Medicine, Biomedical Engineering, or Public Health

Target Years of

Experience:

2-5 years of experience in Clinical Research or Regulatory Affairs

Years’ Experience

Required:

Minimum 3 years, maximum 10 years of relevant experience in PSUR and PMCF writing, clinical evaluation, or post‑market surveillance.

• Review and summarize scientific literature.
• Reports instances of complaints/adverse events from literature to GCH.
• Maintains database of peer‑reviewed literature.
• Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
• Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
• Develop state of the art on product family for its intended purpose.
• Create & maintain plans and reports for regulatory authorities.
• Review/approve other documentation for device development.
• Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.

• Advances use of work document
• EU MDR knowledge
• Literature analysis for PSUR and CE documents
• Microsoft Skills
• PMCFR
• PSUR Medical Writer
• Understanding of EU MDR safety and Performance

• 10+ of project coordination/management experience