Quality Assurance And Regulatory Affairs Manager

Light Tree Technology; Gurugram District; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Light Tree Technology India Pvt. Ltd. is seeking an experienced Regulatory Affairs leader to drive global regulatory strategy and ensure compliance across international markets.

You will lead submissions for FDA, EU MDR, Health Canada, and other markets, manage lifecycle registrations for Medical Devices and IVDs, and oversee regulatory documentation such as Technical Files and CERs. You will collaborate with R&D, Quality, Manufacturing, and leadership to support product launches and expansions

Qualifications

• 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.

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.

Skills

Leadership

Stakeholder management

Communication

Cross-functional collaboration

Regulatory leadership

Education

Biomedical Engineering

Biotechnology

Pharmacy

Life Sciences

Regulatory Affairs

Job description

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 innovative medical device technologies
• Growth-oriented and collaborative environment
• Competitive compensation package