Principal International Regulatory Operations Specialist

About the Role Abbott is seeking a Principal International Regulatory Operations Specialist to join the Diabetes Care Division on-site in Alameda, CA. This role provides subject-matter expertise and hands-on execution to ensure efficient and compliant regulatory processes across the product lifecycle. The successful candidate will work across functions to identify emerging regulations, interpret impact, develop gap assessments, and coordinate actions with owners, while communicating updates to stakeholders. The position may influence department initiatives and lead cross-functional projects, including preparation or oversight of worldwide registrations.

What You'll Do

• Contribute regulatory input to product and process change plans triggered by new or revised regulations/standards; ensure affected dossiers, technical documentation, labeling, and procedures are updated on time.
• Coordinate with regional Regulatory Affairs to update submission strategies and registration maintenance in response to regulatory changes.
• Establish and maintain a structured horizon-scanning log for priority jurisdictions; publish concise impact assessments with owner, due date, and evidence links.
• Lead or co-lead cross-functional working sessions to document decisions, actions, and closure evidence; track progress against external compliance dates.
• Assist in SOP development and review; provide regulatory input to product lifecycle planning.
• Revisit and compare regulatory outcomes with initial concepts to recommend future actions.
• Assist in developing regional regulatory strategy and update strategy based on regulatory changes.
• Understand regulatory history/background to assess regulatory implications for approval in class/therapeutic/diagnostic context.
• Determine market access issues to anticipate regulatory obstacles.
• Determine and communicate submission and approval requirements.
• Participate in risk-benefit analysis for regulatory compliance.
• Assess acceptability of documentation and deliver gap assessments with closure plans and evidence.
• Monitor impact of changing regulations on submission strategies.
• Maintain annual licenses, registrations, listings (as applicable).
• Assist compliance with product post-marketing approval requirements.
• Assess external communications relative to regulations; review regulatory aspects of contracts.
• Assist with label development and review for compliance before release.
• Contribute to the development and functioning of the crisis/issue management program.
• Provide regulatory input for product recalls and recall communications.
• Support knowledge sharing by facilitating training and providing guidance to peers on new/updated requirements.

What We're Looking For

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, Life Sciences, Biology (or equivalent vocational qualifications).
• Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
• Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
• Strong collaboration across QA, R&D, Clinical, Labeling, and Operations; cross-functional experience preferred.
• 2-3 years of regulatory experience is preferred but candidates from QA, R&D/support, engineering, scientific affairs, operations or related areas may be considered.

Nice to Have

• RAC (Regulatory Affairs Professionals Society) certification.
• Additional degrees in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or related fields.
• Additional cross-functional experience across QA, R&D, Clinical, Labeling, and Operations.

Compensation & Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
• A company recognized as a great place to work in dozens of countries and named one of the most admired companies in the world by Fortune.
• A culture that supports diversity, working mothers, female executives, and scientists.