Senior Executive/ Manager - Regulatory Affairs (Medical Devices & IVD)
GNT Page Private LimitedRole Overview
GNT Page Private Limited is hiring a Senior Executive/ Manager - Regulatory Affairs (Medical Devices & IVD). This is a full-time role in New Delhi. Part of GNT Page Private Limited's Pharmacy hiring, posted last week. Full responsibilities, required qualifications, and the apply link are listed in the description below.
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Job Description
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 info@gntpage.com or WhatsApp at 8929700006
Frequently Asked Questions
How do I apply for the Senior Executive/ Manager - Regulatory Affairs (Medical Devices & IVD) position at GNT Page Private Limited?
Use the Apply button above to submit your application directly to GNT Page Private Limited. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.
Where is the Senior Executive/ Manager - Regulatory Affairs (Medical Devices & IVD) position at GNT Page Private Limited located?
This position is based in New Delhi. GNT Page Private Limited has not indicated remote or hybrid options for this role, so candidates should plan for on-site work.
What does a Senior Executive/ Manager - Regulatory Affairs (Medical Devices & IVD) at GNT Page Private Limited earn?
GNT Page Private Limited has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.
When was the Senior Executive/ Manager - Regulatory Affairs (Medical Devices & IVD) role at GNT Page Private Limited posted?
This role was posted on June 10, 2026 (12 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.
How much experience does the Senior Executive/ Manager - Regulatory Affairs (Medical Devices & IVD) role at GNT Page Private Limited require?
This is a senior-level position. Most senior roles call for 5+ years of directly relevant experience. GNT Page Private Limited lists their specific requirements in the description below, so review the must-have qualifications closely before applying.
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