Regulatory Affairs - Medical Device

Syrma Johari Medtech

4 - 6 years

5 - 7 Lacs

jodhpur

Posted:3 hours ago| Platform:

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Skills Required

iso 13485 regulatory affairs medical devices regulatory compliance fda

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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