Hays | Regulatory Affairs Officer | new delhi

5 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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