The Head of Regulatory Affairs will lead the regulatory function for Healthineers, Zone India, ensuring compliance with national and international regulations while supporting the company’s strategic objectives. This role requires an experienced leader who can navigate the dynamic regulatory environment, advocate for the company’s interests, and enable the successful registration, approval, and lifecycle management of medical devices in the Indian market.
The individual will act as the primary point of contact with regulatory authorities, including the Central Drugs Standard Control Organization (CDSCO), and drive cross-functional collaboration to align business goals with regulatory requirements. Additionally, they will play a critical role in ensuring the organization adheres to evolving global standards and supports innovation while maintaining the highest levels of safety, quality, and compliance.
Key Responsibilities
Regulatory Strategy Development
Define and drive the regulatory vision and strategy for CRM products, aligning with Healthineers business goals.
Establish a roadmap for regulatory submissions, approvals, and compliance for new and existing product lines.
Lead initiatives to address regulatory challenges in emerging areas, such as digital health, artificial intelligence, and interoperability.
Leadership and Team Management
Build and lead a high-performing regulatory team, fostering a culture of excellence, innovation, and accountability.
Provide mentorship and career development opportunities to regulatory staff.
Act as the primary regulatory advisor to the leadership team, providing guidance on risk management and compliance.
Regulatory Submissions and Approvals
Oversee the preparation, submission, and maintenance of regulatory dossiers.
Ensure timely guidance and approval while managing regulatory interactions and inspections.
Advocate for streamlined regulatory pathways by engaging with regulators and industry groups.
Compliance Oversigh