Global Regulatory Affairs Lead – Medical Devices

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

Benefits offered by this job

Free HIP PPO medical coverage

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Principal Regulatory Affairs Specialist for its Vascular Division, on-site in Santa Clara, CA or Temecula, CA. You will lead regulatory strategies for endovascular devices, manage global submissions, and partner with Regulatory, Quality, Clinical, R&D, Manufacturing and others to ensure lifecycle regulatory compliance.

The role requires extensive knowledge of US/EU regulatory pathways, 510(k)/PMA submissions and EU MDR, with opportunity to mentor junior colleagues and drive

Qualifications

• Bachelor’s Degree in Scientific discipline (e.g., Chemistry, life sciences, biology).
• Experience in regulatory submissions for medical devices/pharma.
• Experience with 21 CFR 820, ISO 13485, EU MDR/IVD directives.

Responsibilities

• Develop and execute global regulatory strategies for medical devices.
• Prepare regulatory submissions and documentation independently.
• Lead regulatory assessments for design, manufacturing, labeling, and process changes.
• Maintain regulatory registrations, licenses, and technical documentation.
• Collaborate with cross-functional teams to ensure timely regulatory deliverables.

Skills

Regulatory submissions

Medical devices

FDA regulations

Cross-functional teamwork

Education

Bachelor's degree in science

Tools

EDMS

PLM systems

eQMS

Job description

Abbott is seeking a Principal Regulatory Affairs Specialist for its Vascular Division, on-site in Santa Clara, CA or Temecula, CA. You will lead regulatory strategies for endovascular devices, manage global submissions, and partner with Regulatory, Quality, Clinical, R&D, Manufacturing and others to ensure lifecycle regulatory compliance.

The role requires extensive knowledge of US/EU regulatory pathways, 510(k)/PMA submissions and EU MDR, with opportunity to mentor junior colleagues and drive