Regulatory Affair Officer
2 weeks ago
Create and review of documents used in design and development, monitor audits of various departments and quality control areas.
- Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
- Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
- Manage non-conformance, corrective action preventive actions, and deviation.
- Develop and support the implementation of departmental and divisional policies and procedures.
- Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
- Review and sign off on product changes for compliance with applicable regulations.
- Participate with peersin the formulation of overall direction, processes, systems, and talent development for the Quality organizations.
- Manage and renew all the regulatory registrations.
- To prepare and manage technical file/dossier for product with regulatory agencies (CE,CDSCO).
- Take on the role as Management representative for organization and manage ISO 13485:2016 QMS by coordinating with internal and external cross functional teams.
- Coordinate and manage QMS and product audits (internal and external)
- Managing post market surveillance of products and coordinating reports to regulatory authorities as required.
**Job Types**: Full-time, Regular / Permanent
**Salary**: Up to ₹500,000.00 per year
Schedule:
- Day shift
**Experience**:
- total work: 2 years (required)
**Speak with the employer**
+91 9289425813
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