Global Regulatory Strategy Lead, Medical Devices

Thornton Tomasetti; Temecula (CA); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott seeks a Principal Regulatory Affairs Specialist to join the Vascular Division on-site in Temecula, CA or Santa Clara, CA. You will provide regulatory leadership for a portfolio of endovascular medical devices and guide global regulatory strategies throughout the product lifecycle.

The role requires preparing FDA submissions (510(k)/PMA), EU MDR activities, and close collaboration with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, and Marketing to ensure compliant, timely

Qualifications

• Bachelor’s Degree in Scientific discipline (Chemistry, Life Sciences, Biology) or equivalent.
• Experience in regulatory submissions for medical devices or pharma.
• Knowledge of 21 CFR 820, ISO 13485, EU MDR/IVD directives.

Responsibilities

• Develop and execute global regulatory strategies for product changes, lifecycle management, and new developments.
• Prepare regulatory submissions and documentation for medical devices.
• Lead regulatory assessments for design, manufacturing, labeling, and process changes.
• Collaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, and Marketing teams to ensure timely regulatory deliverables.
• Support FDA submissions (510(k), PMA) and EU MDR activities, including documentation updates.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

QMS/ISO knowledge

FDA interactions

Education

Bachelor’s degree in scientific field

Tools

EDMS

PLM systems

eQMS

Job description

Abbott seeks a Principal Regulatory Affairs Specialist to join the Vascular Division on-site in Temecula, CA or Santa Clara, CA. You will provide regulatory leadership for a portfolio of endovascular medical devices and guide global regulatory strategies throughout the product lifecycle.

The role requires preparing FDA submissions (510(k)/PMA), EU MDR activities, and close collaboration with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, and Marketing to ensure compliant, timely