Provide end-to-end regulatory consulting to medical device manufacturers, importers, and legal manufacturers.

Independently handle CDSCO registrations & licenses:

- Class AD medical devices
- MD-3, MD-5, MD-9, MD-14, MD-15, MD-42, MD-43
- Import, manufacturing, loan license & post-approval changes
- Prepare, review, and validate CE MDR (2017/745) documentation for clients: Technical File / Design Dossier
- GSPR checklist
- Risk Management (ISO 14971) PMS & PMCF plans

CER (in coordination with clinical experts) Support US FDA compliance & submissions:
- Establishment Registration & Device
- Listing 510(k) submission strategy and review

FDA QSR (21 CFR 820) gap assessments

Act as a regulatory interface between clients, notified bodies, CDSCO, and international consultants.

Team Leadership & Mentoring Provide ISO 13485 consulting:

- QMS setup, gap analysis, and optimization SOP drafting and review Act as Lead Auditor / Internal Auditor for:
- ISO 13485 internal audits
- Supplier audits Mock regulatory audits (CDSCO / FDA / NB readiness) Review CAPA, change control, deviations, and risk files from a regulatory risk perspective.

📌 Regulatory Affairs Executive (Delhi)
🏢 ELT Corporate
📍 Delhi