Manager - Regulatory Affairs/Quality Assurance - Medical Devices

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