Manager, Regulatory Affairs

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology. We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the development, registration, commercialization, and post-market compliance of Noctrix Health’s medical devices. This role will help ensure regulatory strategies and deliverables are executed accurately, compliantly, and on schedule throughout the product lifecycle. The Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering, Operations, Marketing, and external regulatory partners to provide regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post-market regulatory activities. The ideal candidate combines strong medical device regulatory expertise with excellent project management skills and the ability to independently drive complex regulatory initiatives across multiple functions. This position reports to the Senior Vice President, Clinical & Regulatory Affairs . This is a full-time, hybrid position that is located at our Pleasanton headquarters. Responsibilities: Provide regulatory guidance to cross-functional teams supporting new product development, design changes, risk management, commercialization, and product lifecycle activities Perform and maintain regulatory assessments for product modifications, software and firmware updates, labeling changes, manufacturing changes, and new product development activities Serve as the Regulatory Affairs project lead for FDA and international regulatory submissions, developing submission strategies, timelines, deliverables, and cross-functional execution plans Prepare, review, compile, and submit regulatory applications, technical documentation, and responses to regulatory authorities Support and manage U.S. regulatory submissions, including 510(k) submissions and other applicable premarket activities Support international regulatory submissions and registrations across applicable global markets Maintain product registrations, establishment registrations, regulatory listings, licenses, and other required regulatory records Track regulatory commitments, submission milestones, renewals, and reporting requirements to ensure timely completion Serve as a primary Regulatory Affairs liaison with external partners, including European Authorized Representatives, regulatory consultants, and applicable regulatory authorities Review and approve promotional, advertising, labeling, and marketing materials to ensure compliance with applicable regulations and approved product claims Lead post-market regulatory reporting and vigilance activities, including assessment, submission, tracking, and documentation of reportable events Perform Medical Device Reporting (MDR) assessments and support reporting determinations in accordance with applicable regulatory requirements Collaborate with Quality, Clinical Affairs, and Post-Market Surveillance teams to support complaint trend reporting, PSURs, periodic regulatory reports, and other post-market deliverables Administer and maintain regulatory electronic submission platforms and accounts, including FDA Electronic Submission Gateway (ESG), WebTrader, and other applicable regulatory systems Monitor evolving U.S. and international regulatory requirements and assess potential impacts to products, processes, registrations, and regulatory strategies Communicate…