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

Skills: medical devices,in vitro diagnostics (ivd),documentation,software medical devices