Kokul Rajan

About Kokul Rajan

Regulatory Medical Writer and PMS Analyst with over 3.5+ years of experience in EU MDR 2017/745 compliance, clinical evaluation, post-market surveillance, and regulatory documentation for Class medical devices. Proven expertise in CER, CEP, PMSR, PSUR, PMCFP, and PMCFER development, systematic literature review, risk-benefit analysis, and global regulatory standards including ISO 13485, ISO 14971, and 21 CFR 820. Skilled in complaint handling, root cause analysis, vigilance reporting, and stakeholder communication. Adept with tools like EndNote, Zotero, Grammarly, PerfectIt, MS Office, and TrackWise. Recognized as “Knowledge Champion – 2024” for excellence in regulatory compliance and training delivery.

Experience

1. Medical Writer

   HCLTech

   Dec 2021 — Present · Madurai, IN

   Roles & Responsibilities:Clinical Evaluation & Regulatory Compliance:• Developed Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class IIa, IIb, and medical devices, ensuring EU MDR 2017/745 compliance.•Conducted risk-benefit analyses for CERs in alignment with ISO 14971.Post-Market Surveillance & Risk Analysis:•Authored Post Market Surveillance (PMS) documents including PMS Plans (PMSP), PMS Reports (PMSR), and Periodic Safety Update Reports (PSUR).•Developed Post Market Clinical Follow-Up (PMCF) Plans and Reports (PMCFP, PMCFER) to monitor real-world performance and safety.•Analyzed internal PMS data and external vigilance databases (FDA MAUDE, FDA Recall, BfArM, Swissmedic, MHRA) to identify potential risks.Systematic Literature Review & Data Analysis:•Designed and executed systematic literature searches, developing search strings, protocols, and reports using databases like PubMed, Medline, Embase, Cochrane, Google Scholar.•Conducted critical appraisal and summarization of literature for regulatory submissions.Technical Writing & Document Quality Assurance:•Ensured technical accuracy, clarity, and adherence to Good Documentation Practices (GDP) using Grammarly, PerfectIt, and EndNote.•Conducted proofreading, editing, and quality checks to maintain compliance with regulatory standards.Stakeholder Communication & Training:•Collaborated with global stakeholders to gather project requirements, resolve compliance issues, and facilitate regulatory submissions.•Conducted training sessions for project teams on regulatory writing, literature review methodologies, and EU MDR compliance.

Education

• Mohamed Sathak A.J. College Of Pharmacy

  Bachelor's degree

  2013 — 2017

• JSS University (Jagadguru Sri Shivarathreeshwara University),Mysore

  Master of Pharmacy

  2018 — 2020