Prepare and submit regulatory dossiers for product registrations, import licenses, and amendments to the CDSCO.
Maintain up-to-date knowledge of Indian medical device regulations (Medical Device Rules, 2017 and amendments).
Liaise with CDSCO, state licensing authorities, and third-party regulatory consultants.
Support Quality Assurance in audits, product recalls, and field safety corrective actions.
Ensure compliance with India-specific labeling, documentation, and advertising regulations.
Monitor and assess changes in regulatory guidelines and communicate impact to cross-functional teams.
Maintain regulatory files and tracking systems for timely renewals and updates.
Collaborate with global regulatory teams to ensure consistent strategies and compliance.

Requirement:

Master s degree in Pharmacy or a related field
5 8 years of hands-on experience in regulatory affairs for medical devices and experience with Class C & D devices preferred
Strong knowledge of CDSCO regulations and submission pathways
Excellent communication and project management skills
Familiarity with ISO 13485, EU MDR, and US FDA regulations is a plus

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