Regulatory Affairs Officer

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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