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

- Strong 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.
- Robust 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 (Delhi)
🏢 ELT Advisors
📍 Delhi