Manager, Regulatory Affairs

The role

The Manager, Regulatory Affairs will lead and execute regulatory activities for medical device development, registration, commercialization, and post-market compliance. This person provides regulatory guidance to cross-functional teams and manages submissions and global registrations.

What you will do

• Provide regulatory guidance to cross-functional teams for product development and lifecycle activities
• Perform regulatory assessments for product modifications, software, firmware, and labeling changes
• Serve as Regulatory Affairs project lead for FDA and international regulatory submissions
• Prepare, review, compile, and submit regulatory applications and technical documentation
• Support U.S. regulatory submissions including 510(k) submissions
• Support international regulatory submissions and registrations
• Maintain product registrations, establishment registrations, and regulatory records
• Track regulatory commitments, submission milestones, and renewals
• Serve as a primary Regulatory Affairs liaison with external partners and regulatory authorities
• Review and approve promotional, advertising, labeling, and marketing materials

Required qualifications

• 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
• Strong technical writing skills
• Excellent written and verbal communication skills

Nice to have

• 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

About the company

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. The team consists of medical device specialists, neuroscientists, and consumer electronics engineers.