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Active4w ago

Manager, Regulatory Affairs

Noctrix Health·📍 Pleasanton, California, United States

Employment

Full-Time

Work mode

On-site

Experience

SENIOR LEVEL

Salary

$150K – $180K/yr

Role overview

Job description

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 deli

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What they are looking for

Skills & requirements

Qualification

Advanced degree in Regulatory Affairs, Engineering, Life Sciences, or a related discipline Regulatory Affairs Certification (RAC) Experience within a startup or growth-stage medical device organization Experience serving as the regulatory lead or project manager for successful 510(k) submissions Experience with EU MDR and international medical device registrations Experience supporting connected, wearable, software-enabled, or electro-medical devices Experience with software and firmware change assessments Experience preparing or supporting PSURs and other post-market regulatory deliverables Experience interacting directly with FDA or other regulatory authorities Experience supporting FDA inspections, notified body audits, or other regulatory inspections

Department · Regulatory Affairs

Noctrix Health logo

Hiring company

Noctrix Health

View the company profile, current openings and hiring details.

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