Regulatory Manager

Light Tree Technology; Gurugram District; On-site; INR 2,500,000 - 4,200,000; Full time

Benefits offered by this job

Competitive compensation

Global exposure

Growth-oriented environment

Job summary

Light Tree Technology is seeking a senior Regulatory Affairs leader to drive global submissions and lifecycle management for medical devices. You will coordinate with FDA, EU MDR, Health Canada, and other authorities to ensure compliant product launches and registrations.

Ideal candidates bring 8+ years of regulatory experience, strong leadership, and a proven track record of international approvals. This role offers global exposure and a competitive compensation package.

Qualifications

• 8+ years of Medical Device Regulatory Affairs experience.
• Proven success in obtaining international regulatory approvals (FDA/EU MDR/Health Canada).
• Strong leadership and stakeholder management skills.

Responsibilities

• Lead regulatory strategy and submissions for global markets.
• Maintain regulatory portals and lifecycle compliance for medical devices and IVDs.
• Coordinate with authorities, notified bodies, and testing labs; manage audits and inspections.

Skills

Regulatory affairs

FDA regulations

EU MDR

Leadership

Education

Bachelor's or Master's in Biomedical Engineering or related

Job description

Role & responsibilities

• Lead regulatory strategy and submissions for the US FDA, Health Canada, EU MDR, UKCA/MHRA, TGA Australia, China NMPA, Brazil, and other global markets.
• Must have a proven track record of successfully handling 510(k), ARTG, Health Canada, and EU MDR submissions.
• Maintain applicable government and regulatory portals, including CDRH, FDA FURL, GUDID, MDUFA, EUDAMED, and other relevant systems.
• Manage registrations, approvals, renewals, and lifecycle compliance for medical devices and IVDs.
• Develop regulatory pathways, including device classification, applicable FDA regulations, product codes, and regulatory strategies, and plan product launches in MDSAP-member countries.
• Coordinate with regulatory authorities, notified bodies, testing laboratories, and certification agencies.
• Manage regulatory reporting to MDSAP-member countries and EU authorities, as applicable, in the event of adverse events or other reportable incidents occurring in the market.
• Prepare and maintain Technical Documentation/Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs), Risk Management Files, UDI documentation, and other regulatory documentation.
• Support global product launches and market expansion into regulated markets.
• Must have experience with US FDA inspections, including handling Form 483 observations.
• Manage and respond to regulatory queries raised by MDSAP authorities and other regulatory authorities in applicable markets.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, applicable IEC standards, and other international regulatory requirements.
• Provide regulatory guidance and support to R&D, Quality, Manufacturing, and Executive Management teams.

Preferred candidate profile

• 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 or SIMD) and Active medical devices
• 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