Global Regulatory Affairs Manager

Company Profile

This Gujarat-based medical device innovator has over 20 years of experience in sports medicine. Exporting to 40+ countries, they specialize in orthopedic implants and instruments that support procedures like ACL reconstruction and rotator cuff repair. Known for precision and innovation, their products help improve surgical outcomes worldwide.

Location : Sanand, Ahmedabad

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.
• Regulatory affairs strategy and coordination with Internal and external team for Asia, Africa, ANZ, Middle East, Europe and LATAM countries.
• Coordinate with the Sales & Marketing team for business continuity and center of contact for all regulatory matters.
• 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.
• Manage post approval changes in Global market for all products
• Ensure that regulated processes and systems are always inspection ready.
• 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.
• Manage, train and guide the team members as and when required.

Contact Person

Anjali Batheja

9723300064