Medical Writers

Job Title: Medical Writer Medical Devices / IVD / SaMD

Experience:

Qualification:

Medical Writer

Medical Devices, In Vitro Diagnostics (IVD), and Software as a Medical Device (SaMD)

Key Responsibilities

• Author, review, and update clinical and regulatory documents for Medical Devices, IVD, and SaMD
• Prepare documents such as:
• Clinical Evaluation Reports (CER)
• Clinical Evaluation Plans (CEP)
• Post-Market Clinical Follow-up (PMCF) plans and reports
• Risk Management Documents
• Performance Evaluation Reports (PER) for IVD
• Literature Reviews and Summaries
• State of the Art (SOTA) Docs and other necessary Documents.
• Ensure compliance with EU MDR (2017/745), IVDR (2017/746), FDA, ISO 13485, ISO 14155, CDSCO, Health Canada regulatory agencies as per applicable guidance documents
• Collaborate with cross-functional teams including Regulatory Affairs, Clinical, Quality, and R&D
• Perform systematic literature searches and data analysis to support clinical and regulatory submissions
• Ensure consistency, scientific accuracy, and regulatory alignment across documentation
• Support audits, submissions, and responses to regulatory queries
  

Key Skills & Competencies

• Strong hands-on experience in Medical Device, IVD, and SaMD documentation
• In-depth knowledge of:
• EU MDR & IVDR requirements
• FDA medical device regulations, CDSCO, PMDA (Japan), Health Canada Regulatory Requirements
• GCP, ISO standards, and clinical research methodologies
• Proficiency in clinical data interpretation and scientific writing
• Experience with post-market surveillance and vigilance documentation
• Excellent written and verbal communication skills
• Strong attention to detail and ability to manage multiple projects independently
  

Preferred Skills

• Experience with global regulatory submissions (EU, US, UK, HC, Japan, India (CDSCO) etc.)
• Familiarity with software validation documentation for SaMD
• Experience working in regulated environments and client-facing roles