Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Overview Join a growing neurovascular medical device team supporting regulatory compliance and product lifecycle activities for innovative technologies used to treat stroke and other neurovascular conditions. This onsite position (4 days/week) partners closely with engineering, quality, clinical, and commercial teams to support global regulatory strategy and market access.Key ResponsibilitiesProvide regulatory guidance for product changes and lifecycle management activities.Prepare and support regulatory submissions including Pre-Subs, IDEs, PMAs, PMA Supplements, and 510(k)s.Support EU MDR compliance, CE Mark activities, and technical documentation.Assess product, labeling, manufacturing, and process changes for regulatory impact.Collaborate cross-functionally to ensure regulatory requirements are integrated throughout the product lifecycle.Support interactions with regulatory authorities and Notified Bodies.Review promotional materials for regulatory compliance.Maintain regulatory documentation and support audits as needed.QualificationsRequiredBachelor's degree in Science, Engineering, or related field.4+ years of medical device Regulatory Affairs experience (or advanced degree with 2+ years of experience).Experience supporting FDA submissions and regulatory compliance activities.Ability to manage multiple projects in a regulated medical device environment.PreferredRAC certification.Experience with 510(k), IDE, PMA, or international regulatory submissions.Knowledge of EU MDR, ISO 13485, and ISO 14971.Experience supporting global regulatory compliance and market access initiatives.

Location: Irvine, CA (onsite 4 days/week) Travel: Minimal travel required.

Work Authorization: Must be authorized to work in the U.S. without sponsorship.