Regulatory affairs officer

3 days ago


New Delhi, India Hays Full time
On-Call Contractor for Regulatory Affairs in Medical Device Compliance
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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