Jagdish Chavan

Results-driven Regulatory Affairs professional with hands-on experience in Medical Device Reporting (MDR), adverse event processing, post-market surveillance, complaint handling, and FDA/EU MDR compliance. Proficient in 21 CFR 803/820/807, ISO 13485:2016, and EU MDR 2017/745. Currently processing eMDRs and submitting adverse event reports to FDA's MAUDE database at Genpact.

Adept at root-cause investigation, regulatory documentation, and quality management system (QMS) activities. Seeking to leverage deep regulatory expertise in a Complaint Handling & Vigilance specialist role.

Senior Associate – Regulatory Affairs & MDR Processing at Genpact (2025-05 – Present)

• Analyze and classify electronic Medical Device Reports (eMDRs) for FDA regulatory compliance as per 21 CFR 803.
• Ensure timely submission of adverse event reports to the FDA's MAUDE database, meeting mandatory reporting timelines.
• Investigate complaint events and device issues collaboratively with cross-functional teams to determine reportability.
• Maintain post-market surveillance records and support CAPA processes in line with QMS requirements.
• Utilize Power BI and Excel dashboards to track, trend, and report adverse event incidents and compliance metrics.
• Support internal and external audits; adhere to GMP, GLP, and FDA guidelines throughout all activities.

Regulatory Affairs Associate at Phoenix Innovative Healthcare Pvt. Ltd. (2024-07 – 2025-05)

• Managed regulatory compliance activities for medical devices in accordance with ISO 13485:2016, 21 CFR 820, and IEC 60601-1:2005.
• Conducted usability testing and human factors evaluation per IEC 62366 to support device safety assessments.
• Led 510(k) pre-submission activities: identified predicate devices, compiled technical documentation, and coordinated with FDA standards requirements.
• Involved in Post-Market Surveillance (PMS) activities including complaint intake, event classification, and reporting.
• Designed and reviewed Instructions for Use (IFU), SOPs, and product labeling (inner box labels, artwork) per regulatory requirements.
• Prepared device technical files per IEC, ISO, ASTM, and IS standards supporting both US FDA and global submissions.
• Developed and maintained company website content in compliance with applicable regulatory requirements.

Regulatory Affairs Consultant (Remote) at OMC Medical Private Limited (2024-01 – 2024-07)

• Performed regulatory research and analysis for medical device products targeting UK/EU markets.
• Compiled and reviewed regulatory submissions documentation including technical files and compliance records.
• Managed project deliverables and timelines for regulatory dossier preparation.

Master of Science in Regulatory Affairs – Sanjivani College of Pharmaceutical and Research (2023 – 2024)

Bachelor of Pharmacy in Pharmacy – Shri. Vivekanand Nursing Home Trust's College of Pharmacy (2019 – 2022)

Diploma in Pharmacy in Pharmacy – Anurag College of Pharmacy, Bhandara (2017 – 2019)