Senior Manager Regulatory Affairs

4 weeks ago

Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full time

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.

Take charge of your next career move

Apply directly or email your CV to Ansuya@uhr.co.in or Unitedind@uhr.co.in and open doors to valuable opportunities with a trusted recruitment partner.

Contact Person

Ansuya Satish / Anjali Batheja

9824350317 / 9723300064

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