Senior Manager Regulatory Affairs
3 weeks ago
Designation: Regulatory Affairs Manager
Industry: Medical Devices (Orthopedic devices preferred)
Experience required: 10 to 15 Years
Location: Sanand, Ahmedabad
Company overview:
A globally‑recognized orthopedic medical device firm founded in 2003, delivering cutting-edge sports‑medicine and extremities implants and instruments across six continents
Driven by innovation, quality and clinical value, the team remains privately held and proudly owned, maintaining a collaborative, family‑style culture.
Duties and Responsibilities:
Responsible for strategic development, implementation, maintenance, and overall success of the company's regulatory project approvals in different countries.
Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business Strategy.
Global coordination for regulatory planning and execution, for the development and market introduction of Company Products
Regulatory compliance and medical device registration in Asia, Africa, ANZ, Middle East, Europe and LATAM countries. Management of a team of RA coordinators for different countries.
Draft, review, edit, and maintain all departmental policies and procedures, including Post approval changes, regulatory review of order, label and IFU requirements, Language translation needs, Marketing claims etc.
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Contact Person
Ansuya Satish / Anjali Batheja
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