Company: Light Tree Technology India Pvt. Ltd.

Light Tree Technology is a fast-growing medical device and technology company developing innovative healthcare solutions for global markets. We are seeking an experienced Regulatory Affairs leader to drive global regulatory strategy and compliance across multiple international markets.

Key Responsibilities:
• Lead regulatory strategy and submissions for FDA, Health Canada, EU MDR, UKCA/MHRA, TGA Australia, China NMPA, and other global markets
• Manage registrations, approvals, renewals, and lifecycle compliance for Medical Devices and IVDs
• Prepare and maintain Technical Files, Design Dossiers, CERs, Risk Management Files, UDI, and regulatory documentation
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, IEC standards, and international regulations
• Coordinate with regulatory authorities, notified bodies, testing laboratories, and certification agencies
• Lead audits, inspections, CAPA activities, and quality compliance initiatives
• Provide regulatory guidance to R&D;, Quality, Manufacturing, and Executive Management teams




• Support global product launches and expansion into regulated markets

Qualifications:
Bachelor's or Master's degree in Biomedical Engineering, Biotechnology, Pharmacy, Life Sciences, Regulatory Affairs, or related discipline
8+ years of Medical Device Regulatory Affairs experience
Strong expertise in FDA, EU MDR, Health Canada, TGA, MHRA, and NMPA regulations
Proven success in obtaining international regulatory approvals
Excellent leadership, stakeholder management, and communication skills

Preferred:
• Experience managing multi-country registrations simultaneously
• Knowledge of Software as a Medical Device (SaMD) and connected healthcare products
• Experience with CE Marking and Post-Market Surveillance

What We Offer:
• Leadership role with global exposure
• Opportunity to work on cutting-edge medical device technologies
• Growth-oriented and collaborative environment
• Competitive compensation package

📌 Quality Assurance And Regulatory Affairs Manager (Gurugram)
🏢 Light Tree Technology
📍 Gurugram