Senior Manager Regulatory Affairs

2 weeks ago

Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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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