[RQA-197] - Associate Regulatory Affairs

Updated: March 08, 2024 08:43 PM GMT

Full-time Job in Hazira, Gujarat

Elevate Life Science

Surat, Gujarat, India

To prepare/submit/review technical documentation for the international registration of products
- To prepare/update/review the Technical Master File for the current product
- To prepare/review Technical Change Notifications to the Regulatory Authority
- To review Application/ Query related to DCGI (GMP, Manufacturing license), state FDA, local FDA, Central FDA (CDSCO).
- To keep record, purchase & communication of regulatory, statutory guidelines & applicable Harmonized, International standards for a medical device.
- To maintain & Update RA status
- To participate in an internal audit as per the internal audit plan.
- To work for additional QMS-related document preparation of elevate whenever required.
- To check, maintain & communicate for all certificates related to elevate,
- Responsible for communication with Raw material suppliers for technical documents of raw material.
- Skills & Competencies
- Acquainted and continual updating of knowledge with national & international... More Detail