Regulatory Executive Medical Devices

14 hours ago

Noida, Uttar Pradesh, India SR Strategy Services Llp Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Role & responsibilities

  1. Prepare, compile, and assist in submission of regulatory applications/dossiers for medical devices and IVDs under MDR 2017.
  2. Support licensing/registration processes (Forms MD-5, MD-14, MD-15, MD-16, MD-24 etc.) for multiple products and clients.
  3. Liaise with CDSCO, State Licensing Authorities, and notified bodies during submission and approval processes.
  4. Track and manage multiple regulatory projects simultaneously, ensuring adherence to timelines.
  5. Maintain regulatory documentation, trackers, and compliance records for all client projects.
  6. Coordinate with SRSS internal teams and client stakeholders to collect required technical and compliance documentation.
  7. Monitor regulatory amendments, CDSCO notices, and guidance impacting medical devices and IVDs.
  8. Support post-approval activities including license renewals, variations, and responding to authority queries.

Preferred candidate profile

  • Bachelors/Masters degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or related discipline.
  • 13 years of experience in regulatory affairs for medical devices and/or IVDs under Indian MDR 2017
  • Familiarity with CDSCO online portal (MD Online System), device/IVD classification and submission formats.
  • Understanding of ISO 13485 and Quality Management Systems preferred.
  • On-site role based at Noida, Uttar Pradesh
  • Strong organizational skills to manage multiple projects concurrently.
  • Excellent written and verbal communication skills.
  • Proficiency in MS Office Suite.

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