; 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 new-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, and government authorities
- ;Strong understanding of medical device manufacturing and applicable regulatory requirements
- ;Experience with radiation-emitting equipment, X-Ray systems, or radiology products will be highly preferred
- ;Robust documentation, communication, coordination, and problem-solving skills
- ;Good command of Microsoft Excel, MIS reporting, and regulatory tracking systems
- ;Ability to independently manage multiple regulatory projects and meet compliance deadlines

; Preferred Profile

- ;Candidates from Medical Devices, Radiology, Healthcare Equipment, Pharmaceuticals, or Manufacturing industries
- ;Experience with X-Ray, C-Arm, DR, or other radiation-emitting medical equipment will be an added advantage
- ;Candidates with experience managing both domestic and international regulatory certifications will be preferred
- ;Immediate joiners will be preferred

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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