Join a leading medical device company in beautiful North San Diego! We're seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory submissions and compliance initiatives. If you're passionate about navigating complex regulatory landscapes and enjoy collaborating cross-functionally, this is your opportunity to make a major impact.

Key Responsibilities:

• Prepare U.S. and international product submissions.
• Develop and maintain Technical Files and product labeling.
• Draft and coordinate recall (correction/removal) reports and related activities.
• Support cross-functional teams with regulatory input during product development and lifecycle management.
• Develop regulatory strategies for new products and design changes.
• Review and assess regulatory impact of design and quality system changes (ECOs, MCOs, NCMRs, SDRs).
• Drive process improvements and ensure compliance across regulatory processes.
• Lead Health Hazard Evaluations for post-market product issues.
• Provide regulatory guidance during FDA, Notified Body (e.g., BSI), and other regulatory inspections.

Qualifications:

• Bachelor's degree with a minimum of 5 years of Regulatory Affairs experience in the medical device industry.
• Hands-on experience with 510(k), IDE, PMA, annual reports, MDRs, Vigilance Reports, and international registrations.
• Strong knowledge of FDA QSR, ISO 13485, and EU Medical Device Directive (MDD) or MDR.
• Excellent written and verbal communication skills.
• Confident public speaker and collaborative team player.
• Demonstrated leadership and mentorship abilities.
• Strong organizational skills with the ability to prioritize and manage multiple projects.