Senior Regulatory Affairs Specialist - Vascular (on-site)

Abbott Vascular seeks a Senior Regulatory Affairs Specialist to support regulatory compliance and product lifecycle management for vascular medical devices. The role involves premarket submissions, postmarket compliance, and strategic regulatory planning across global markets on an on-site basis in California.

Responsibilities

• Provide regulatory input to product lifecycle planning and regional strategy development
• Assess and compile quality, preclinical, and clinical documentation for regulatory submissions
• Prepare, review, and submit regulatory filings to authorities worldwide
• Support postmarket compliance, labeling development, and change management processes
• Interact and negotiate with regulatory authorities during product development and review

Requirements

• Bachelor's degree in related field or equivalent education and work experience
• 3-4 years regulated industry experience (medical devices, nutritionals, or equivalent)
• 2-3 years regulatory experience or related roles (quality assurance, R&D, scientific affairs)
• Strong verbal and written communication with regulatory agencies
• Excellent organizational skills and attention to detail
• Knowledge of FDA submissions (510(k), PMA) and EU regulatory pathways preferred
• Experience with FDA and EU Notified Body interactions preferred