Principal International Regulatory Product Specialist

Responsibilities

• Provide subject-matter expertise and hands-on execution to ensure compliant business processes for diabetes care products
• Contribute regulatory input to product and process change plans triggered by new or revised regulations and standards
• Coordinate with regional regulatory affairs teams to update submission strategies and registration maintenance
• Establish and maintain a structured horizon-scanning log for priority jurisdictions and publish impact assessments
• Lead cross-functional working sessions to document decisions, track progress, and ensure compliance with external dates
• Assist in SOP development, review, and providing regulatory input to product lifecycle planning
• Evaluate regulatory history and background to assess implications for product approvals and market access
• Maintain annual licenses, registrations, and listings while assisting with post-marketing approval requirements
• Support label development and review for compliance and contribute to crisis/issue management programs

Requirements

• Bachelor's Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology)
• Experience in regulatory submissions for Pharmaceuticals, In vitro diagnostic devices, and/or medical devices
• Knowledge of 21 CFR 820 and ISO 13485
• Knowledge of the Medical Devices Directive (93/42/EEC) or IVD Directive (98/79/EC)

Preferred Qualifications

• Advanced degree in science, math, engineering, or medical fields
• Regulatory Affairs Certification (such as RAC)
• 2-3 years of experience in regulatory affairs, quality assurance, R&D, or engineering
• Experience with EU and other international medical device or pharma regulations
• Experience with design controls, IVDR, and highly matrixed business environments
• Proficiency with Excel, PowerPoint, and Veeva Vault

Benefits

• Career development opportunities within an international company
• Eligibility for free medical coverage via the Health Investment Plan (HIP) PPO plan
• Retirement savings plan with high employer contribution
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits for obtaining a bachelor's degree

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. We serve people in more than 160 countries.