• Developing thorough strategies to penetrate the medical device and IVD markets in India, while ensuring alignment with MDR 2017 regulations.• Experienced in risk class evaluation of medical devices and IVDs, predicate device identification, and medical device grouping• Skilled in filing various medical device applications (MD 3, MD 4, MD 12, MD 14, MD 16, MD41)• Developed and reviewed label texts & Artworks/Labels (Global & India Specific) to ensure compliance with MDR 2017, Legal Metrology Act, Plastic Waste Management Rules.• Well-versed in the Medical Devices Rules, 2017, and adept at utilizing the CDSCO MD Portal and NSWS Portal for regulatory compliance.• Registered multiple medical devices on the IPDMS portal in accordance with the latest DPCO 2013 and NPPA regulations.• Effectively communicated with regulatory agencies (e.g., CDSCO, USFDA) to address inquiries, resolve potential issues, and facilitate smooth regulatory processes.• Create monthly newsletters on medical devices & IVDs, highlighting the latest regulatory updates.• Skilled in identifying relevant BIS standards for medical devices and facilitating BIS registrations as per regulatory requirements.• Experienced in developing and preparing Clinical Evaluation Performance Plans for medical devices in accordance with regulatory guidelines.• Proficient in identifying and assigning GMDN and UMDN codes for various medical devices.