---
title: 'Manager, Regulatory Affairs at Noctrix Health'
canonical: 'https://feeny.ai/job/manager-regulatory-affairs-noctrix-health-pleasanton-rww4jfgpsbbq'
type: 'job'
last_seen: '2026-09-11'
---

# Manager, Regulatory Affairs at Noctrix Health

- **Company:** Noctrix Health
- **Location:** Pleasanton, CA
- **Posted:** 2026-08-13
- **Last confirmed live:** 2026-09-11
- **Apply:** https://job-boards.greenhouse.io/noctrixhealth/jobs/5388618008

## 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 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 regulatory changes, risks, requirements, and recommendations to cross-functional stakeholders and leadership
- Support regulatory inspections, audits, agency inquiries, and Quality System activities related to Regulatory Affairs
- Identify opportunities to improve regulatory processes, documentation, tracking, and cross-functional execution as the organization grows

Requirements:

- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related scientific or technical discipline
- Minimum of 5 years of Regulatory Affairs experience within the medical device industry
- Demonstrated experience with medical device regulatory submissions, post-market regulatory compliance, and product lifecycle management
- Strong working knowledge of FDA medical device regulations, Medical Device Reporting requirements, and applicable international regulatory frameworks
- Experience performing regulatory assessments for new product development, design changes, software or firmware updates, labeling changes, and product modifications
- Experience preparing, supporting, or managing 510(k) submissions
- Experience supporting international or OUS medical device registrations and submissions
- Knowledge of post-market vigilance requirements, complaint reporting, MDR assessments, and applicable regulatory reporting obligations
- Experience reviewing promotional, advertising, labeling, or marketing materials for regulatory compliance
- Strong project management skills with demonstrated ability to coordinate complex regulatory deliverables across multiple functions
- Strong technical writing skills with experience preparing regulatory documentation and communicating complex information clearly
- Ability to independently manage multiple regulatory projects, priorities, and deadlines
- Excellent written and verbal communication skills with the ability to collaborate effectively with internal stakeholders, external partners, and regulatory authorities
- Strong attention to detail and commitment to regulatory documentation accuracy and compliance

Preferred Qualifications:

- 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

Compensation:

- Base Pay: $150,000–$180,000 per year
- Annual Bonus Eligibility

## About Noctrix Health

## Company Overview
- **One-liner**: Noctrix Health develops clinically validated wearable neuromodulation devices as non-pharmaceutical alternatives for managing chronic neurological disorders, starting with Restless Legs Syndrome (RLS).
- **Entity Type**: Private (Acquired by ResMed in May 2026 for $340M)
- **Headquarters**: Pleasanton, California, United States
- **Founded**: 2018
- **Founders**: Jonathan Charlesworth (CSO), Justin Kelly (SVP, Product), Steve Lien (SVP, Patient Access), Shriram Raghunathan (CEO)

## Core Business
- **Primary industry/industries**: Medical Device Manufacturing, Neuromodulation, Wearable Therapeutics, Sleep Health
- **Target customers**: B2B (healthcare providers, sleep clinics, DMEs) and B2C (patients with Restless Legs Syndrome)
- **Mission or purpose statement**: To innovate the next generation of clinically-validated wearable therapeutics to address the unmet needs of millions of people living with chronic medical conditions.

## Products & Services
- **[Nidra® Therapy (TOMAC Therapy)]**: A prescription wearable device that delivers Tonic Motor Activation (TOMAC) therapy to treat Restless Legs Syndrome (RLS). It is a non-pharmaceutical, clinically validated alternative that uses neuromodulation to alleviate symptoms without disrupting sleep. The therapy has received favorable inclusion in the American Academy of Sleep Medicine (AASM) clinical practice guidelines and has dedicated CMS reimbursement codes.

## Market Standing
- **Valuation/Market Cap**: Acquired by ResMed for $340 million (announced May 6, 2026).
- **Key Metric**: Total funding raised was approximately $57M (per CB Insights) to $107.2M (per LinkedIn), with the most recent round being a Series C - II. Annual revenue is estimated at $2.5M (pre-acquisition).
- **Notable Investors/Partners**: ResMed (acquirer), OrbiMed, Treo Ventures, The Blue Venture Fund, Sandbox Industries, Bridge Bank.
- **Growth Signals**: Headcount grew 100% YoY to 110 employees. The company secured dedicated CMS reimbursement codes for Nidra therapy. The therapy was included in new AASM clinical practice guidelines for RLS. The company was acquired by ResMed for $340M in May 2026, signaling strong validation and a major growth trajectory.

## Competitive Advantages
- **First-to-market with a non-pharmaceutical wearable for RLS**: Nidra therapy is a clinically validated, drug-free alternative for a condition affecting ~7% of adults globally, offering a significant differentiator in a market dominated by pharmaceuticals.
- **Strong clinical and regulatory moat**: The therapy has been included in AASM clinical practice guidelines and has dedicated CMS reimbursement codes, creating high barriers to entry for competitors.
- **Backed by ResMed**: The $340M acquisition by the global leader in sleep health provides immense resources, distribution channels, and market credibility.

## Strategic Focus
- **Post-acquisition scaling**: Following the acquisition by ResMed, the primary focus is on rapidly scaling U.S. commercialization, expanding market access, and integrating Nidra therapy into ResMed's global sleep health portfolio.
- **Expanding indications**: While currently focused on RLS, the company's platform technology has potential for treating other chronic neurological disorders.
- **Building the commercial engine**: The company is actively hiring across sales, marketing, patient access, and engineering roles to support its growth.

## Why Work Here
- **Patient-centered mission**: The company is deeply mission-driven, with a culture that prioritizes improving patient lives. Employees describe a strong sense of purpose in delivering life-changing therapy.
- **High-growth environment**: With 100% YoY headcount growth, a recent $340M acquisition, and 50+ open roles, this is a fast-scaling company with significant career advancement opportunities.
- **Culture of transparency and problem-solving**: The company emphasizes core values like "embrace the unknown," "build trust through transparency," and "win as a team," fostering a collaborative and innovative environment.
- **Remote-friendly**: Many roles are listed as remote, including sales, patient access, and support positions, though some engineering and marketing roles are based in Pleasanton, CA, or Pittsburgh, PA.
- **Strong engineering and clinical culture**: The team is a mix of seasoned medical device experts, neuroscientists, and engineers from the consumer electronics world, offering a unique blend of high-tech and life-science work.

## Sources
1. [noctrixhealth.com](https://noctrixhealth.com/)
2. [noctrixhealth.com/careers](https://noctrixhealth.com/careers/)
3. [greenhouse.io](http://job-boards.greenhouse.io/noctrixhealth)
4. [linkedin.com](https://www.linkedin.com/company/noctrix-health)
5. [cbinsights.com](https://www.cbinsights.com/company/noctrix-health)

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