Hiring: Sr. Regulatory Affairs Manager Company: NeuroPace Location: Mountain View, CA Job Posted Time: 2026-09-14 13:18:08 Employment Type: Hybrid Target Skills & Keywords : AI, Machine Learning, Microsoft Office, Project Management, Risk Management About the job Experience: •6-8 years' of regulatory affairs medical device industry experience required, with at least 3 years of people management preferred. •8 years' of regulatory affairs medical device industry experience required, with at least 3 years of people management preferred. •At least 3 years of people management preferred. Required Skills: •Implements regulatory strategies for new and modified products to facilitate timely regulatory approval in support of business goals and objectives. •As a core team member on product development teams, provides regulatory feedback, guidance throughout the product development cycle, and coordinates team inputs for submissions. •Partners with Clinical Affairs on the development of effective clinical trial strategies. •Manages and prepares regulatory submissions of varying levels of complexity (including PMA 180-Day Supplements, Real Time Review Supplements, 30-Day Notices, Annual Reports and IDE submissions). •Reviews and approves device labeling and promotional/advertising materials, including making recommendations to ensure compliance. •Develops and maintains positive relationships with regulatory agency reviewers throughout the total product life cycle. •Provides regulatory training/mentoring to cross-functional teams. •Develops and implements departmental policies and procedures. Qualifications: •Bachelor’s degree in a scientific or technical discipline required; advanced degree and/or professional certification(s) preferred. •Thorough understanding and extensive experience with FDA regulations; PMA experience required. Experience with international regulations preferred. •Working understanding of highly technical and complex active implantable medical device systems, including hardware and software, is required. •Demonstrated experience with the regulatory requirements for specialized technical disciplines, including cybersecurity, artificial intelligence, and machine learning preferred. •Extensive knowledge of product development process and design controls, and an excellent grasp of change control and verification and validation requirements. •Proficient knowledge of clinical trial strategy, study design and related submissions. •Regulatory project management experience required, including excellent project and time management skills and the ability to effectively manage multiple projects. •Extensive experience in the preparation of high-quality regulatory submissions. Highly developed written and oral communication, technical writing and editing skills and proficiency with Microsoft Office and Adobe. •Excellent research, analytical, organizational and interpersonal skills, with ability to influence a variety of stakeholders. Compensation: •$160,000 - $190,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!