Regulatory Affairs Specialist

2 weeks ago


Faridabad Haryana India, Haryana vueverse. Full time

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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).
  • Ensure compliance with ISO 13485, EU MDR 2017/745, US FDA 21 CFR Part 820, and local regulatory guidelines.
  • Review labeling, IFUs, and promotional materials for compliance.
  • Manage product registration, renewals, and post-market submissions.
  • 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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