Regulatory Affairs

4 days ago

Jodhpur, Rajasthan, India Syrma Johari Medtech Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

The Regulatory Affairs (RA) & Global Registration Executive/Manager will be responsible for managing end-to-end global regulatory submissions, maintaining compliance with regional and international regulatory requirements, and facilitating timely registration and market access for medical devices across multiple geographies.

  • Prepare and submit dossiers (510k, CE, CDSCO, etc.) as per country-specific regulations. - Maintain registration records and handle renewal processes.
  • Monitor global regulatory updates and assess product impact. -
  • Coordinate with QA, R&D, and marketing for data collection and documentation. -
  • Respond to regulatory queries and deficiency letters.
  • Support audits and inspections by regulatory bodies.

Preferred candidate profile

  • Knowledge of global regulations: USFDA, MDR, CDSCO, TGA, SFDA, etc.
  • Hands-on with portals: eSTAR, SUGAM, EUDAMED.
  • Experience in technical file creation, labeling, UDI, and ISO 14971 risk documentation
  • Strong communication and documentation skills -
  • Attention to detail and time management
  • Proficient in MS Office - Problem-solving and multi-tasking abilities

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