We are looking for a Manager-Regulatory Affairs for a Medical Devices set up
Location : Delhi
Position details:
- Heads the India RA-QA Function, Reporting to the Country Head & APAC Regulatory Head. Manages a team of 4 members (3-RA & 1-QA)
Job responsibilities:
- Develop, plan and execute strategies and tactics to ensure timely registration and import license approvals in India (DCG (I) and DOT) and South Asia
- Lead RA/QA teams; provide clear objectives to team members, supervise their work, mentor them and provide them with a clear career development path
- Develop and present Annual Operating Plan and Country Business Review for the RA/QA departments
Ensure 100% Compliance and Achievement of QMS Objectives including:
- Field Event Reporting/Product Returns
- Field Safety Corrective Actions/Ship Holds
- Warehouse and Cross Functional Departmental Audits
- Quick resolution of non-conformities, concerns as observed during internal/external audits
- SOP development and maintenance
- Management of document control files
- QMS training to all employees of the organization
- Management Review Meetings on QMS systems
- Effective warehouse management
- ISO 13485:2003 Quality Management System certification
- Support the business with tender related documentation
Kindly contact 0120-4822910.
Garvita Gupta
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