Assistant Manager/Manager - Regulatory Affairs - Medical Devices

Candidate should be experience in India Regulatory Affairs and Medical Devices.

- Manage, plan and execute the preparation, review and submission of product registrations, import licenses and other approvals from regulatory agencies

- Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in Indian Sub-Continent.

- Submit and track registration/re-registration applications with the authorities.

- Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.

- Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance .

- Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.

- Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.

- Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance.

- Supporting the Marketing Teams on Tender related issues

- Development, implementation and maintenance of regulatory systems pertaining to regulatory document management within the department and organization.

- Interface and coordinate with regulatory agencies/competent authorities (CDSCO, DGDA, State FDA etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.