Senior Manager Regulatory Affairs

3 days ago

Ahmedabad, Gujarat, India beBeeRegulatoryAffairsManager Full time ₹ 9,00,000 - ₹ 12,00,000

Key Responsibilities:

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Develop Regulatory Strategy: Design, implement, and maintain a comprehensive regulatory compliance strategy to meet global market requirements for products.\

Ensure Alignment with Business Goals: Develop and execute plans to align the company's overall business strategy with regulatory objectives.\

Lead Global Regulatory Planning: Coordinate regulatory planning and execution for product development and market introduction in countries around the world.\

Manage Regulatory Compliance: Maintain regulatory compliance in countries across Asia, Africa, ANZ, Middle East, Europe, and LATAM. Ensure adherence to regulations and guidelines for medical devices. \

Team Management: Lead and manage a team of regulatory affairs coordinators in different regions. Foster collaboration and ensure seamless communication within the team.\

Policies and Procedures: Develop, review, edit, and maintain departmental policies and procedures. Ensure alignment with regulatory requirements and company standards.\

Language Support: Provide language translation needs for marketing claims, order labels, and IFU requirements. Ensure accuracy and consistency across languages.\

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Key Qualifications:

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  • 10-15 years of experience in regulatory affairs, preferably in the medical device industry.
  • Strong knowledge of regulatory requirements for medical devices in multiple countries.
  • Excellent leadership, communication, and project management skills.
  • Ability to work in a fast-paced environment and prioritize tasks effectively.
  • Strong analytical and problem-solving skills.

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