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

GNT Page Private Limited; New Delhi; On-site; INR 500,000 - 800,000; Full time

Benefits offered by this job

Competitive compensation

Collaborative team culture

Opportunity to lead regulatory strategy

Job summary

GNT Page Private Limited is seeking a Regulatory Affairs Executive in New Delhi to oversee regulatory submissions for medical devices and IVD products. The ideal candidate will have 2-4 years of experience in this domain, with strong knowledge of CDSCO processes and Indian medical device regulations.

The role involves preparing regulatory dossiers, maintaining licenses, and ensuring compliance with regulations. A Master's degree in Life Sciences or related fields is required. A collaborative work environment and competitive salary are offered.

Qualifications

• 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) and Class A–D device classification.
• Familiarity with technical documentation requirements.

Responsibilities

• Prepare and submit regulatory dossiers for new product registrations.
• Maintain and manage regulatory licenses ensuring compliance.
• Review product labeling and other documents for compliance.

Skills

Knowledge of CDSCO processes

Strong written and verbal communication skills

Proficiency in MS Office (Word, Excel)

Education

Master's degree in Life Sciences, Pharmacy, Biomedical Engineering or related field

Tools

Regulatory tracking tools

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.