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 New Delhi
🏢 ELT Corporate
📍 New Delhi