Regulatory Affairs Officer
19 hours ago
Workload: Approximately 40-50 hours per year, on-call
Key Requirements:
- Expertise in Indian Medical Device Regulations: Comprehensive knowledge of Indian medical device legislation and regulatory requirements, particularly for Class C and D products.- Regulatory Experience: Proven experience in obtaining regulatory approvals and maintaining licenses for medical devices, including change reporting and renewals.- Scientific Background: Ideally, a background in a scientific discipline
Responsibilities:
- Regulatory Consulting: Provide expert advice on the implementation of Indian medical device regulations.- Support Change Assessments: Assist with the execution of change assessments, query responses, new product registrations, and renewals.- Submission Dossiers: Aid in the preparation of submission dossiers in compliance with Indian regulatory authorities and Indian MDR (Medical Device Rules).- Review and Submission: Review and submit applications (changes, renewals, new product registrations) via the CDSCO (Central Drugs Standard Control Organization) portal.- Communication with Authorities: Coordinate with local authorities in collaboration with the authorized agent.- Vigilance Support: Provide support in handling vigilance cases.- License Optimization: Offer advice on optimizing existing licenses, such as cost reduction strategies.- Predicate Evaluation: Ideally, support the evaluation of suitable predicates for product registration.
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