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 professional 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 Oversight
- Ensure that our equipment's meet the required regulatory standards as set by CDSCO.
- Oversee the implementation of risk management frameworks, including adherence to ISO 13485 and knowledge of SaMD products which must comply with IEC 62304 (Software Lifecycle Processes) and ISO 14971 (Risk Management).
- Lead regulatory responses to audits, inspections, and post-market surveillance requirements.
- Cross-functional Collaboration
- Partner with Govt affairs, Quality, Business Areas, Marketing and Legal team to integrate regulatory requirements.
- Provide regular updates and input to ensure compliance with applicable standards.
- Support with strategies by aligning regulatory timelines with market goals.
Qualifications
- Education: Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related fields. Advanced degrees (e.g., MBA, Ph.D.) are an advantage.
Experience:
- Minimum 1015 years of regulatory experience, with at least 5 years in a leadership role.
- In-depth understanding of India's Medical Devices Rules, 2017, CDSCO guidelines, and applicable standards (e.g., ISO 13485, ISO 14971).
- Familiarity with global regulations like FDA (21 CFR), EU MDR/IVDR, and other regional requirements for international market access.
- Proven track record of managing regulatory strategies for medical device company.
- Exceptional leadership, communication, and negotiation skills.
- Strategic thinker with a proactive approach to problem-solving.
- Ability to navigate complex regulatory landscapes while maintaining agility.
