Global Regulatory Strategy Lead – Medical Devices

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

Benefits offered by this job

Free HIP PPO medical coverage

Generous retirement plan

Tuition reimbursement

FreeU education benefit

Recognized as a great place to work

Job summary

Abbott is seeking a Principal Regulatory Affairs Specialist to join the Diabetes Care division at the Alameda, CA site. This on-site role focuses on leading global regulatory submissions for medical devices and digital health solutions, spanning US/EU/global markets.

You will shape submission strategy, coordinate cross-functional teams, and ensure compliance with evolving regulatory requirements while driving timely approvals and post-market activities.

Qualifications

• Bachelor’s Degree in Scientific discipline (e.g., Chemistry, life sciences).
• Experience in regulatory submissions for In Vitro Diagnostic Devices and/or Medical Devices.
• Familiar with 21 CFR 820, ISO 13485, IVDR/MDR and related regulations.

Responsibilities

• Develop global regulatory strategies across the product lifecycle.
• Lead regulatory submissions and negotiations with authorities.
• Provide technical leadership on complex regulatory issues for business units.
• Ensure compliance and manage labeling reviews and post-market requirements.
• Maintain licenses and registrations and oversee regulatory metrics.

Skills

Regulatory strategy

Global submissions

Cross-functional leadership

Regulatory communications

Travel readiness

Education

Bachelor’s degree in Scientific discipline

Tools

MS Office

Job description

Abbott is seeking a Principal Regulatory Affairs Specialist to join the Diabetes Care division at the Alameda, CA site. This on-site role focuses on leading global regulatory submissions for medical devices and digital health solutions, spanning US/EU/global markets.

You will shape submission strategy, coordinate cross-functional teams, and ensure compliance with evolving regulatory requirements while driving timely approvals and post-market activities.