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Regulatory Affairs Specialist (Medical Devices)

Regulatory Affairs Specialist (Medical Devices)

vueverse.Vellore, IN
1 day ago
Job description

Role Overview :

Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.

Key Responsibilities :

  • Prepare and submit regulatory dossiers for product approvals and renewals.
  • Develop and maintain Technical Files, DMR, and DHF .
  • Ensure compliance with CDSCO, FDA 21 CFR Part 820, and EU MDR .
  • Review labeling, IFUs, and promotional materials for compliance.
  • Monitor regulatory updates and standards relevant to medical devices.
  • Support internal and external audits , providing necessary documentation.
  • Collaborate with R&D, QA, and manufacturing teams for regulatory input.

Qualifications :

  • B.Pharm / M.Pharm / M.Sc (Regulatory Affairs, Biotechnology, or Life Sciences).
  • Minimum 6 years’ experience in Regulatory Affairs for medical devices.
  • Strong knowledge of device registration process and QMS standards .
  • Experience interacting with Notified Bodies / Regulatory Authorities preferred.
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    Regulatory Specialist • Vellore, IN