Director, Medical Events Group & NPR – Abbott Diabetes Care

Abbott • Alameda, CA

20d

About The Position

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. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: 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 - an affordable and convenient path to getting a bachelor’s degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists The Opportunity The Director of the Medical Events Group (MEG) and No Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory reporting for Abbott’s Diabetes Care products. This role ensures worldwide compliance with FDA, ISO 13485, EU MDR, and other global regulatory standards. The Director will provide strategic leadership, oversee medical event reporting processes, and act as a key representative during regulatory inspections and audits. Additionally, this role will oversee the No Product Return Investigation Team, ensuring timely and thorough investigations for cases where product returns are not available.

Requirements

• Bachelor’s or Master’s, in a scientific, medical, or technical discipline.
• Minimum 8–10 years of experience in Quality Systems, Regulatory Affairs, or Quality Assurance within the medical device industry.
• At least 5 years of leadership experience managing teams and complex regulatory processes.
• Expertise in global medical device reporting regulations (FDA, MHRA, Health Canada, EU MDR, etc.).
• Strong verbal and written communication skills at all organizational levels.
• Proficiency in Microsoft Office Suite and familiarity with regulatory reporting systems.

Nice To Haves

• Prior experience in medical event reporting or post-market surveillance.
• Advanced knowledge of global vigilance requirements and risk management frameworks.

Responsibilities

• Define and implement global medical device reporting and vigilance strategies for Abbott Diabetes Care.
• Develop and enforce policies for capturing and documenting reportable events to comply with global requirements.
• Ensure adherence to CFR 803, 806, 820, ISO 13485, and other international standards.
• Oversee timely and accurate global filing of reportable events (FDA, Health Canada, MHRA, EU MDR, ROW).
• Evaluate product safety issues, highlight risks to senior management, and drive mitigation actions.
• Provide leadership during regulatory audits and inspections (FDA, ISO, etc.).
• Lead and develop the Medical Events Group team, fostering a culture of compliance and continuous improvement.
• Manage the No Product Return Investigation Team to ensure robust Device History Review (DHR) and documentation for non-returned product cases.
• Establish and maintain quality metrics to enhance process efficiency and data reporting.
• Represent Abbott in external regulatory discussions and standard-setting activities.

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 - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees