Manager – Regulatory Affairs
Neomadvisors · Saudi Arabia · Posted 30 Oct 2026
About the job
A Manager – Regulatory Affairs is sought by a company to lead regulatory activities for IVD kits, medical devices, and manufacturing facilities in Bangalore.
Responsibilities
- Drive regulatory approvals, product evaluations, and registrations
- Prepare and submit regulatory dossiers and manage CDSCO submissions
- Liaise with regulatory authorities and evaluation institutions
- Ensure compliance with Indian Medical Device Regulations
- Conduct regulatory audits of manufacturing facilities
- Identify compliance gaps and drive corrective actions
Requirements
- Proven experience in securing regulatory approvals for IVD kits and medical devices
- Strong knowledge of CDSCO and Medical Devices Rules, 2017
- Experience managing manufacturing licences, registrations and product evaluations
- Strong regulatory authority liaison and stakeholder management skills
- Regulatory/Quality Auditor certification is an added advantage
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