Position Overview We are seeking a highly motivated and detail-oriented Regulatory Medical Writer to join our team The ideal candidate will have experience in creating clinical regulatory documents for the Central Drugs Standard Control Organization CDSCO the EU Medical Device Regulation MDR and other regulatory bodies The Regulatory Medical Writer will play a crucial role in developing key documents such as Clinical Evaluation Plans CEP Clinical Evaluation Reports CER Post-Market Surveillance PMS Reports and other regulatory submissions Responsibilities Collaborate with cross-functional teams to gather and analyze clinical data for inclusion in regulatory submissions Develop and maintain expertise in CDSCO EU MDR regulations and other regulatory guidelines and standards related to clinical evaluations and post-market surveillance Draft review and edit Clinical Evaluation Plans CEP Clinical Evaluation Reports CER Post-Market Surveillance PMS Reports and other regulatory documents as required Ensure accuracy completeness and compliance of regulatory documents with applicable regulations and guidelines Provide support during regulatory inspections and audits as needed Stay informed about changes in regulatory requirements and guidelines and communicate implications to relevant stakeholders Qualifications Bachelor s degree in a relevant scientific or technical discipline An advanced degree is preferred At least 2-3 years of experience in regulatory medical writing within the pharmaceutical biotechnology or medical device industry Should be proficient in literature search engines like PubMed Cochrane etc and capable of extracting relevant clinical studies for documentation Experience with creating clinical regulatory documents for CDSCO and EU MDR is preferred Strong understanding of regulatory requirements and guidelines governing clinical evaluations and post-market surveillance Excellent written and verbal communication skills with the ability to convey complex scientific information clearly and effectively Detail-oriented with robust organizational and time management skills Ability to work independently and collaboratively in a fast-paced deadline-driven environment