Director of Medical Device Regulatory Affairs

6 days ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,50,00,000
Senior Regulatory Compliance Leader

The Senior Regulatory Compliance Leader will be responsible for ensuring compliance with regulatory requirements and building a long-term strategy for excellence in regulatory affairs.

This senior leadership role requires strategic direction, regulatory expertise, and operational leadership to ensure effective product registrations, quality system compliance, and post-market vigilance.

Key responsibilities include:

  • Strategic Leadership & Compliance (30%)
    • Define and implement the local Quality Management System (QMS) in alignment with global sales QMS and Indian regulatory requirements.
    • Provide regulatory and quality leadership to ensure all products meet compliance with Indian laws and global standards.
    • Drive the regulatory affairs strategic plan for India, aligning with business and global objectives.
  • Regulatory & Post-Market Vigilance (30%)
    • Ensure timely and compliant product registration processes to support market access.
    • Oversee post-market vigilance activities, including complaint handling, incident reporting, and corrective/preventive actions.
    • Serve as the primary liaison with regulatory bodies including CDSCO, Ministry of Health & Family Welfare, Bureau of Indian Standards, and certification bodies.
  • People & Organizational Leadership (25%)
    • Lead, mentor, and develop the regulatory affairs team, including managers and specialists.
    • Foster a culture of accountability, collaboration, and continuous improvement.
    • Retain and grow high-potential talent while ensuring team alignment with business goals.
  • Product Registration & Market Access (15%)
    • Manage timely and compliant product registration processes to support market access.
    • Anticipate regulatory changes and proactively develop strategies to ensure compliance readiness.

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