Regulatory Affairs Specialist

About the role

ISC Commercial Regulatory Affairs Team at Philips works to ensure medical device products meet regulatory requirements across the Indian subcontinent. The Regulatory Affairs Specialist supports the team by managing product registrations, monitoring regulatory changes, preparing submissions and coordinating with authorities and internal stakeholders. Gurgaon, hybrid work model (3 days onsite, 2 days remote).

What you’ll do

• Prepare and submit regulatory dossiers for product registrations and changes
• Monitor and assess regulatory updates across multiple ministries
• Coordinate with test labs, customs and government agencies for compliance
• Support RA manager on supply chain regulatory queries
• Assist government sales team with regulatory clarifications
• Ensure compliance with ISO 13485 and related standards

What you’ll bring

• Bachelor's degree in Biomedical Engineering
• 6-10 years regulatory affairs experience
• Knowledge of India and international medical device regulations (CDSCO, BIS, AERB, etc.)
• Familiarity with ISO 13485, 9001, IEC 60601
• Understanding of health care standards for diagnostic X‑ray, electrical safety, risk management
• Problem‑solving skills for regulatory and product safety issues
• Ability to build relationships with regulatory bodies