Associate Regulatory Affairs
4 days ago
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 regulations and applicability
- Continuous updating of knowledge about changes in regulatory requirements and communicated to relevant internal stakeholders
- Product approvals and certifications
- Timely response and closer to concern regulatory bodies and suppliers
- ISO 9001 & 13485
- Written and business communication skills
- Handling targets and deadlines.
- Minimum 2 - 4 years of experience.
**Plot No 63, Ichchapore G I D C,**
**Industrial Estate,**
**Bhatpore Sachin-Hazira Road Surat,**
**Gujarat, 394510 India**
** +91-XXXXXXXXXX
/8155859481**
**Salary**: ₹250,000.00 - ₹300,000.00 per year
Schedule:
- Morning shift
Ability to commute/relocate:
- Surat, Gujarat: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- regulatory affairs: 3 years (preferred)
- FDA regulations: 2 years (required)
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