Regulatory Affairs Executive

Job Description (JD): Senior Regulatory Executive Position Title Senior Regulatory Executive – Medical Devices Location Sector- 3, Rohini, Delhi Role Overview We are a medical device regulatory consultancy looking for a senior professional who can independently manage multiple clients and geographies across CDSCO (India), CE (EU MDR), and US FDA. This role demands deep regulatory expertise, audit leadership, strong client handling, and the ability to guide teams—not just execute tasks. Qualification & Experience Education: B.Pharm / M.Pharm / B.Tech / M.Tech / MSc (Life Sciences or Biomedical) Experience: 3 –5 years in medical device regulatory consulting / regulatory affairs Prior experience in a consultancy environment is a strong advantage Key Responsibilities -Provide end-to-end regulatory consulting to medical device manufacturers, importers, and legal manufacturers. -Independently handle CDSCO registrations & licenses: •Class A–D 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. Key Skills & Competencies -Strong working knowledge of: •CDSCO Medical Device Rules, 2017 EU MDR 2017/745 •US FDA (21 CFR 820, 807, 510(k)) •ISO 13485 & ISO 14971 -Proven experience as: •Lead Auditor •Internal Auditor -Excellent client communication & documentation skills -Ability to manage multiple clients and tight regulatory timeline