My Client is one of India's leading medical device company. They are in the business of introducing & marketing medical devices in India by partnering with reputed manufacturers and multinational medical device companies.

Regulatory Affairs Roles:

1. To Ensure company production activities complies with Regulatory norms
2. Liaison between Regulatory agencies (DCGI, ISO) and Veiva Scientific
3. Should have Knowledge on ISO 13485 QMS documentation and implementation
4. Knowledge in Preparing and submitting applications and reports to obtain regulatory approval
5. Knowledge in preparing Site Master File, Device Master File as per regulatory norms ( especially for medical devices)
6. Knowledge in preparing Technical Dossier for all the manufactured products, including product information for packaging (Label design) and packaging inserts (IFU) as required by the regulatory approval.
7. Co-ordinates with operations department regarding production to ensure compliance with regulations
8. Assists with the development of standards operating procedure for all departments
9. Coordinates with Operations departments to perform IQ, OQ,PQ and to develop protocols for the same.
10. Coordinates with Operations Departments to perform Validation and to develop validation protocol.
11. Knowledge on Medical device regulations and risk management (ISO 14971)
12. Ability to educate all departments on regulations and policies that require compliance.
13. Ability to manage activities such as audits, regulatory agency inspections or product recalls
14. Coordinate in the development or implementation of clinical trial protocols
15. Develop regulatory strategies and implementation plans for the preparation and submission of new products
16. Investigate Product complaints and prepare documentation and ensure effective and timely
17. resolution of all complaint investigations.

Quality Assurance Roles:

1. Devise procedure to inspect and report quality issues
2. Supervise and guide inspectors, technicians and other staff
3. Assure the reliability and consistency of production by checking processes and final output
4. Report all malfunctions to production executives to ensure immediate action
5. Maintain records of quality reports, statistical reviews and relevant documentation
6. Knowledge on current standards and policies
7. Knowledge to operate and train personnel on HPLC
8. Knowledge on Clean room environment
9. Knowledge on Quality control equipment’s and calibration