Job Overview:

We are seeking an experienced and visionary Head of Quality and Regulatory Compliance (QRC) to lead and oversee all aspects of Quality Assurance and Regulatory Affairs in India.

This senior leadership role is responsible for ensuring compliance with Medical Devices Rules 2017 and global quality standards, while building and executing a long-term strategy for QRC excellence in India.

As a key member of the SAPAC QRC Leadership Team and the India SSU Leadership Team, the incumbent will provide strategic direction, regulatory expertise, and operational leadership to ensure effective product registrations, quality system compliance, and post-market vigilance.

The role has a solid reporting line to the Senior QRC Director, APAC and a dotted line to the Managing Director, India SSU.

Key Responsibilities:

Strategic Leadership & Compliance (30%):

- Define, implement, and oversee 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 QRC strategic plan for India, aligning with business and global objectives.

Regulatory & Post-Market Vigilance (30%):

- Ensure all regulatory submissions, registrations, and filings are completed on time and in compliance with national and global requirements.

- 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 such as TV SD.

People & Organizational Leadership (25%):

- Lead, mentor, and develop the QRC 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.

Internal & External Relationships:

- Internal: India Management Team, Regional QRC Teams, Business Area QRC Teams, Sales, Service, Logistics.

- External: CDSCO, BIS, ISO certification bodies, distributors, and other regulatory authorities.

Qualifications & Experience:

- Bachelor's degree in Engineering, Life Sciences, or a related field (advanced degree preferred).

- Minimum 10+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs, preferably in the medical device industry.

- Proven track record in building and scaling quality systems in compliance with FDA, EU, and Indian medical device regulations.

- Strong knowledge of QSR, QSIT, ISO standards, and international quality frameworks.

- Demonstrated experience in strategic planning, regulatory submissions, audits, and compliance oversight.

- Excellent leadership, influencing, and stakeholder management skills with the ability to operate effectively in a cross-functional global environment.

- Exceptional communication skills (written, verbal, and public speaking).

- Proficiency in MS Office and digital compliance tools.