Senior International Regulatory Operations Lead

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

Benefits offered by this job

Health benefits

Tuition reimbursement

Retirement savings plan

Free medical coverage in HIP PPO

Job summary

Abbott in Alameda, CA seeks a Principal International Regulatory Operations Specialist to lead regulatory submissions and strategic regulatory activities for the Diabetes Care division. You will partner across QA, R&D, Labeling and Operations to ensure compliant, timely documentation and registration worldwide.

This on-site role emphasizes cross-functional collaboration, horizon-scanning, and leadership in regulatory change.

Qualifications

• Bachelor’s Degree in Scientific discipline or equivalent.
• Experience in regulatory submissions for pharma, IVDs or medical devices.
• Familiarity with 21 CFR 820, ISO 13485, MDD/IVDR or related regs.
• RAC certification is a plus.
• Strong Excel and PowerPoint skills; experience with Veeva Vault is advantageous.

Responsibilities

• Contribute regulatory input to product and process change plans.
• Coordinate regional submissions strategies and registration maintenance.
• Establish horizon-scanning logs for priority jurisdictions.
• Lead cross-functional sessions to document decisions and actions.
• Assist in SOP development and regional regulatory strategy updates.
• Evaluate regulatory history to assess implications for approvals.
• Support product recalls and risk-based regulatory activities.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Excel

PowerPoint

Veeva Vault

Documentation

Education

Bachelor’s Degree in Scientific discipline

RAC certification (plus)

Tools

Veeva Vault

Excel

PowerPoint

Job description

Abbott in Alameda, CA seeks a Principal International Regulatory Operations Specialist to lead regulatory submissions and strategic regulatory activities for the Diabetes Care division. You will partner across QA, R&D, Labeling and Operations to ensure compliant, timely documentation and registration worldwide.

This on-site role emphasizes cross-functional collaboration, horizon-scanning, and leadership in regulatory change.