Senior Regulatory Executive – Medical Devices

Location: Sector 3, Rohini, Delhi
Experience: 3–5 Years
Qualification: B.Pharm / M.Pharm / B.Tech / M.Tech / MSc (Life Sciences / Biomedical)
About the Role
We are looking for a Senior Regulatory Executive with hands-on experience in medical device regulatory affairs and consulting. The candidate will independently manage clients and regulatory projects across CDSCO, EU MDR and US FDA.
Key Responsibilities
Handle CDSCO registrations and licenses for Class A–D medical devices.
Manage MD-3, MD-5, MD-9, MD-14, MD-15, MD-42 & MD-43 applications.
Prepare and review EU MDR 2017/745 documentation including Technical Files, GSPR, Risk Management, PMS, PMCF and CER.
Support US FDA Registration & Listing, 510(k) strategy and 21 CFR 820 gap assessments.
Provide ISO 13485 consulting, QMS gap analysis and SOP review.
Conduct ISO 13485 internal audits,



supplier audits and mock regulatory audits.
Review CAPA, change control, deviations and risk management files.
Handle client communication and coordinate with CDSCO, Notified Bodies and international consultants.
Manage multiple projects and mentor junior team members.
Required Skills
Robust knowledge of CDSCO MDR 2017, EU MDR 2017/745, US FDA 21 CFR 820/807, 510(k), ISO 13485 & ISO 14971.
3–5 years of experience in medical device regulatory affairs/consulting.
Consultancy experience preferred.
Strong communication, documentation, auditing and client-handling skills.
Ability to manage multiple clients and regulatory timelines independently.
Apply Now
Join our team and build your career in medical device regulatory consulting.

📌 Senior Regulatory Executive (India)
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