Executive -raqa

2 weeks ago


Thane, India Kids-e-Dental Full time

**Regulatory Affairs**:
Ø **Regulatory Compliance**:Ensure that the company's products are in compliance with local and international at all stages of development, manufacturing, and post-market. Maintain awareness of updates to regulations and inform the team as necessary.Ø **Labeling and Documentation**:Review product labeling and packaging for compliance with regulatory requirements and standards.Ø **Liaison with Regulatory Authorities**:Communicate with regulatory agencies to resolve issues related to product approvals and compliance, as well as follow-up on submissions.Ø **Regulatory Strategy Support**: Support the regulatory team in developing regulatory strategies for new product development and modifications to existing products.2. -**Quality Assurance**:
Ø **Quality Control Documentation**:Assist in the preparation and review of quality control documentation, including batch records, specifications, and test procedures.

Ø **Product Inspections and Audit**s: Participate in internal and external audits to ensure that manufacturing and quality assurance practices are compliant with regulations and internal standards.

Ø **CAPA Management**: Support the Corrective and Preventive Action (CAPA) process by investigating deviations, conducting root cause analyses, and ensuring that corrective actions are implemented.

Ø **Training**: Assist in providing quality-related training to employees on regulatory requirements, quality assurance processes, and industry standards.

Ø **Document Control**: Ensure proper documentation management, ensuring all quality and regulatory documentation is accurate, up-to-date, and in compliance with regulatory guidelines.

3. **Cross-Functional Collaboration**:Work closely with other departments such as Research & Development, Manufacturing, and Marketing to ensure regulatory compliance and quality standards are maintained throughout the product life-cycle.Support the regulatory and quality teams in the preparation of internal reports and presentations for senior management.

Pay: ₹25,000.00 - ₹40,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Provident Fund

Schedule:

- Day shift

Work Location: In person

Expected Start Date: 15/03/2025