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 Responsibilities

• Provide 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.

Qualifications

Required

• Bachelor'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.

Preferred

• RAC 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.