Global Regulatory Lead for Medical Devices – Vascular

Thornton Tomasetti; San Jose (CA); On-site; USD 100,000 - 200,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Tuition reimbursement

Education assistance

Job summary

Abbott is seeking a highly motivated Principal Regulatory Affairs Specialist for our Vascular Division, on-site in Santa Clara, CA or Temecula, CA. You will lead regulatory strategies for peripheral vascular devices, manage complex submissions, and partner with cross-functional teams across regions.

The role requires extensive experience with FDA/EU regulatory pathways, and the ability to navigate global regulatory requirements to support product lifecycle and market approvals.

Qualifications

• Bachelor’s Degree in Scientific discipline (Chemistry, life sciences, biology) or equivalent.
• Experience with regulatory submissions for medical devices, with focus on 21 CFR 820 and ISO 13485.
• Experience preparing regulatory submissions for US/EU and other international markets.

Responsibilities

• Develop and lead global regulatory strategies for product changes and lifecycle activities.
• Independently prepare regulatory submissions and documentation for medical devices.
• Lead regulatory assessments for design changes, manufacturing transfers, and process updates.
• Review and approve engineering change orders, protocols, reports, and risk management documents.
• Support and maintain U.S. and international product registrations, licenses, and approvals.
• Serve as regulatory lead on cross-functional project teams and provide strategic guidance.
• Prepare FDA submissions (510(k), PMAs, PMA supplements) as applicable.
• Support EU MDR activities and notified body interactions.
• Collaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, and other groups.

Skills

Regulatory submissions

FDA submissions

Team collaboration

Regulatory strategy

Education

Bachelor's Degree in Science

Tools

EDMS

PLM systems

eQMS platforms

Job description

Abbott is seeking a highly motivated Principal Regulatory Affairs Specialist for our Vascular Division, on-site in Santa Clara, CA or Temecula, CA. You will lead regulatory strategies for peripheral vascular devices, manage complex submissions, and partner with cross-functional teams across regions.

The role requires extensive experience with FDA/EU regulatory pathways, and the ability to navigate global regulatory requirements to support product lifecycle and market approvals.