Principal Regulatory Affairs Specialist - Vascular (on-site)

Abbott seeks a Principal Regulatory Affairs Specialist for its Vascular Division to lead regulatory strategy and submissions for endovascular medical devices treating peripheral artery disease. The role manages complex regulatory activities across product lifecycle stages and coordinates with cross-functional teams in Santa Clara or Temecula, California.

Responsibilities

• Develop and execute global regulatory strategies for product changes, lifecycle management, and new development
• Prepare regulatory submissions and documentation for medical devices independently
• Lead regulatory assessments for design, manufacturing, and process changes to determine submission requirements
• Review and approve engineering change orders, validation documents, and project-related records
• Prepare FDA submissions including 510(k)s, PMAs, and supplements

Requirements

• Bachelor's degree in scientific discipline such as chemistry, life sciences, or biology
• Experience preparing regulatory submissions for pharmaceutical, diagnostic, or medical devices
• Demonstrated knowledge of 21 CFR 820, ISO 13485, and Medical Devices Directive requirements
• 6-8 years in medical device industry with Class II or Class III device experience
• Professional background supporting medical device regulatory activities
• Experience leading regulatory initiatives for cardiovascular or endovascular products