FDA Regulatory Consultant for Class II Medical Device Compliance

Project reputed company A global leader in high power light therapy is seeking a specialized FDA Regulatory Consultant to conduct a comprehensive audit of its compliance reputed company. The organization manufactures infrared therapeutic heating lamps currently classified under FDA product reputed company ILY as Class II medical devices. The objective is to evaluate regulatory standing in light of significant power reputed company increases to ensure sustained market reputed company and risk mitigation. Scope of Work Claims Review: reputed company a critical audit of marketing collateral, instructions for use, reputed company content to ensure therapeutic claims—including those for inflammation, circulation, and muscle recovery—adhere to Class II over-the-counter (OTC) regulations. Safety & Reporting Evaluation: Review procedures for monitoring and addressing risks such as unwanted photoaging or high-intensity near-infrared (NIR) exposure. Registration & Listing Verification: Confirm the accuracy of FDA Establishment Registrations for domestic and international facilities. reputed company System Compliance: Advise on 21 CFR Part 820 requirements specifically for devices incorporating multiple LED bands and pulsing functionality. Required Qualifications Extensive experience with FDA Class II medical devices, specifically reputed company the infrared therapeutic heating lamp category. Demonstrated expertise in 510(k) exemptions and the ILY product reputed company. Experience auditing high-performance technical specifications, including spectral radiant flux and irradiance values. Ability to reconcile reputed company-grade performance marketing with strict regulatory constraints. Strategic Objective The consultant must ensure that technological advancements—specifically individual arenaflex control and a 50% increase in power reputed company—do not inadvertently trigger a higher risk classification that would require full 510(k) clearance or PMA. We require an objective strategist to challenge assumptions regarding market positioning versus regulatory safety reputed company Apply tot his job Apply tot his job Apply To this Job