? We’re Hiring | Senior Regulatory Executive – Medical Devices

ELT Corporate Pvt. Ltd. is looking for an experienced Senior Regulatory Executive – Medical Devices to join our regulatory consulting team in Sector 3, Rohini, Delhi.

If you have robust expertise in CDSCO, EU MDR, US FDA, ISO 13485 & ISO 14971 and can independently manage clients, regulatory projects and audits, we’d love to hear from you.

? Key Responsibilities

- End-to-end regulatory consulting for medical device manufacturers & importers
- Manage CDSCO Class A–D registrations & licenses
- Handle MD-3, MD-5, MD-9, MD-14, MD-15, MD-42 & MD-43
- Prepare/review EU MDR Technical Files, GSPR, Risk Management, PMS & PMCF documentation
- Support US FDA Establishment Registration, Device Listing & 510(k) strategies
- Conduct ISO 13485 internal, supplier & mock regulatory audits
- Support QMS setup, gap assessments, SOPs, CAPA, change control & risk management
- Coordinate with clients, Notified Bodies,



CDSCO and international consultants
- Lead and mentor junior regulatory professionals

? Required Expertise

✅ CDSCO Medical Device Rules, 2017

✅ EU MDR 2017/745

✅ US FDA – 21 CFR 820, 807 & 510(k)

✅ ISO 13485 & ISO 14971

✅ Lead Auditor / Internal Auditor experience

✅ Strong client communication & documentation skills

✅ Ability to manage multiple clients and regulatory timelines independently

? Qualification

B.Pharm / M.Pharm / B.Tech / M.Tech / MSc (Life Sciences / Biomedical)

? Experience

3–5 years in Medical Device Regulatory Affairs / Regulatory Consulting

Consultancy experience preferred

? Location: Sector 3, Rohini, Delhi

? Position: Senior Regulatory Executive – Medical Devices

? Interested candidates can share their CV with us.

📌 Senior Regulatory Executive (Delhi)
🏢 ELT Advisors
📍 Delhi