Regulatory Manager Medical Devices

• ;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

• ;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

• ;Strong 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

• ;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

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