Global Regulatory Affairs Lead, Medical Devices

Regulatory Jobs; Alameda (CA); On-site; USD 100,000 - 200,000; Full time

Job summary

Abbott is seeking a Principal RA Specialist to lead global regulatory submissions from Alameda, CA. This on‑site role focuses on premarket submissions, clinical trial applications, and post‑market compliance for medical devices and digital health solutions.

You will influence regulatory strategy, interface with agencies worldwide, and guide teams toward compliant, timely submissions. Travel ~5% may be required, and the position offers strong benefits and career growth within a global company.

Qualifications

• Bachelor’s Degree in Scientific discipline (e.g., Chemistry, life sciences, Biology)
• Experience in regulatory submissions for In Vitro Diagnostic Devices and/or Medical Devices
• Experience with 21 CFR 820, ISO 13485, MDR 2017/745 and/or IVDR 2017/746
• 5+ years’ experience in regulatory affairs for Class II/III medical devices and/or biologics/drugs
• Regulatory Affairs Certification (RAC) is a plus
• Ability to travel approximately 5% (including international)

Responsibilities

• Develop global regulatory strategies for product development and lifecycle
• Lead regulatory submissions and manage timelines for approvals
• Provide technical leadership and strategic input on complex regulatory issues
• Monitor regulatory changes and communicate impact to teams
• Negotiate with regulatory authorities during development and review processes
• Ensure labeling and post‑marketing compliance
• Oversee licenses, registrations, and patent information

Skills

Regulatory submissions

Regulatory affairs knowledge

Global regulatory experience

Education

Bachelor’s Degree in Scientific discipline

Job description

Abbott is seeking a Principal RA Specialist to lead global regulatory submissions from Alameda, CA. This on‑site role focuses on premarket submissions, clinical trial applications, and post‑market compliance for medical devices and digital health solutions.

You will influence regulatory strategy, interface with agencies worldwide, and guide teams toward compliant, timely submissions. Travel ~5% may be required, and the position offers strong benefits and career growth within a global company.