; Regulatory Manager Medical Devices

; Location: Mangolpuri, Delhi

; Department: Regulatory Affairs Compliance

; Experience: 47 Years

; Key Responsibilities
- ;Manage end-to-end regulatory affairs, product registrations, approvals, licenses, renewals, and compliance activities
- ;Handle regulatory documentation and submissions with AERB, CDSCO, BIS, DGFT, and other applicable authorities
- ;Manage AERB licensing, approvals, renewals, amendments, and compliance requirements related to radiation-emitting medical equipment
- ;Coordinate product registrations, certifications, technical documentation, and regulatory approvals for medical devices
- ;Manage CE and other international regulatory certifications and support export-market compliance requirements
- ;Prepare and maintain regulatory dossiers, licenses, certificates, declarations, technical documents, and statutory records
- ;Coordinate with government authorities, auditors, consultants, certification bodies, and internal teams for inspections, audits, and approvals




- ;Monitor changes in regulatory requirements and ensure timely implementation across relevant business and product processes
- ;Maintain regulatory trackers, compliance calendars, MIS reports, and documentation systems
- ;Support management during product launches, regulatory due diligence, audits, and recent-market entry activities
- ;Work closely with RD, Quality, Production, Service, and International Business teams to ensure products meet applicable regulatory and certification requirements

; Requirements
- ;Graduate / Post Graduate in Regulatory Affairs, Pharmacy, Life Sciences, Engineering, Medical Devices, or a related field
- ;47 years of hands-on experience in Regulatory Affairs / Regulatory Compliance, preferably in the medical device industry
- ;Strong working knowledge of AERB, CDSCO, BIS, DGFT, CE certifications, and regulatory documentation
- ;Experience handling regulatory submissions, product approvals, renewals, audits, inspections,

📌 Regulatory Manager Medical Devices (New Delhi)
🏢 Edusoft Healthcare
📍 New Delhi