Location: Mangolpuri, Delhi
Department: Regulatory Affairs & Compliance
Experience: 4–7 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 R&D, 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
- 4–7 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
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