About the Job
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 ...
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 e...
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 ca...
Key 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
Required Skills & Abilities
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
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
