Senior Executive/ Manager - Regulatory Affairs (Medical Devices & IVD)

Regulatory Affairs Executive - Medical Devices & In Vitro Diagnostics (IVD)

Department: Regulatory Affairs

Employment Type: Full-Time

Experience: 2–4 Years

About the Role

We are looking for a proactive and detail-oriented Regulatory Affairs Executive to manage

end-to-end regulatory submissions and compliance activities for medical devices and IVD

products in India. The ideal candidate has hands-on experience with CDSCO processes and

is comfortable working cross-functionally with quality, operations, and commercial teams.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for medical devices and IVD products to CDSCO for new product registrations, renewals, and amendments.
• Maintain and manage regulatory licenses, certificates, and approvals — ensuring timely renewals and zero-lapse compliance.
• Review product labelling, IFUs (Instructions for Use), and other supporting documents for regulatory compliance.
• Track and interpret changes in Indian medical device regulations (MDR 2017) and IVD regulations, and assess impact on existing and pipeline products.
• Coordinate with internal teams (QA, R&D, Supply Chain) and external stakeholders (importers, manufacturers, testing labs) to gather regulatory data.
• Assist in handling regulatory queries or inspections.
• Maintain accurate regulatory databases, trackers, and filing systems.

Requirements

• Master's degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.
• 2–4 years of hands-on experience in regulatory affairs for medical devices and/or IVD in India.
• Working knowledge of Medical Devices Rules (MDR) 2017, CDSCO processes, and Class A–D device classification.
• Experience with IVD product registration under Indian regulations.
• Familiarity with technical documentation requirements (technical files, risk management summaries, biocompatibility data, etc.).
• Strong written and verbal communication skills; ability to draft clear regulatory correspondence.
• Proficiency in MS Office (Word, Excel); experience with regulatory tracking tools is a plus.

Good to Have

• Exposure to international regulatory frameworks (CE Marking, ISO 13485, US FDA) is advantageous but not required.
• Experience working with contract manufacturers or importers of medical devices.
• Awareness of upcoming IVD-specific regulatory changes in India.

What We Offer

• A dynamic, growing environment in the medical device and diagnostics sector.
• Opportunity to own and lead regulatory strategy for a diverse product portfolio.
• Competitive compensation commensurate with experience.
• Collaborative team culture with strong leadership support.

Share resume at [Confidential Information] or WhatsApp at 8929700006