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Neko Health · 2 months ago

Senior Regulatory Affairs Engineer (TCI)

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

Neko Health is seeking a Senior Regulatory Affairs Engineer who’s passionate about tackling complex regulatory strategies in the field of medical technology. The role involves ensuring compliance of cutting-edge medical devices with global standards, supporting product development, and maintaining regulatory documentation throughout the product lifecycle.

Artificial Intelligence (AI)Health CareHospital

Responsibilities

Ensure our cutting-edge medical devices meet global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market

Advise on regulatory strategy throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling

Develop and maintain regulatory documentation, including Design History File (DHF), Technical Documentation, as well as Device Master Record (DMR) and Device History Records (DHR)

Prepare, review, and submit documentation for EU MDR, FDA, and other international markets

Participate in post-market surveillance, CAPA, and complaint management activities

Coordinate communications with regulatory bodies and drive certification projects and vigilance activities, ensuring timely reporting and compliance

Guide process owners and product teams to integrate regulatory requirements into our Quality Management System and deliver impactful training on compliance and regulatory topics

Monitor regulatory trends and provide intelligence to keep Neko Health at the forefront of compliance

Qualification

Regulatory AffairsActive Medical DevicesSoftware as Medical DeviceEU MDRFDA CFRISO 13485IEC 60601-1IEC 62304ISO 14971Analytical SkillsFluent EnglishSwedish ProficiencyDetail-orientedCommunication SkillsSelf-motivated