Associate Director, Medical Events Group

In order to make an application, simply read through the following job description and make sure to attach relevant documents. 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. Free medical coverage for employees via the Health Investment Plan (HIP) PPO. An excellent retirement savings plan with high employer contribution. Tuition reimbursement, the student debt program, and education benefits — an affordable and convenient path to a bachelor's degree. A company recognized as a great place to work in dozens of countries and named one of the most admired companies by Fortune. A company recognized for diversity, working mothers, female executives, and scientists. The Opportunity This position is based in Alameda, CA, within the Diabetes Care division, focusing on helping people with diabetes manage their health through innovative products that provide accurate data for better decisions. We are revolutionizing glucose monitoring with new sensing technology. As the Associate Director, Medical Events Group, you will ensure product quality and safety by overseeing medical surveillance and post-market review for all division products. Manage staff responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, and Medical Incident Reports to the EU/EFTA including France, as well as reports for other regions. Represent the division during audits, inspections, and assessments by regulatory agencies like the FDA. Ensure policies, procedures, and processes for medical event reporting comply with global regulatory requirements. Provide metrics on medical events to support product quality management. What You'll Work On Serve as the primary liaison for identifying regulatory, risk management, and legal issues, forwarding them for review. Work with the division Medical Director to recommend strategies and implement processes for global medical device and vigilance reporting. Implement reporting policies and procedures to capture and document all potential reportable events. Ensure compliance with CFR 803, 806, 820, and ISO 13485 in divisional policies and procedures. Manage the Medical Event Group (MEG) and ensure adherence to regulations and procedures. Oversee worldwide post-market surveillance for ADC. Make appropriate filing decisions and ensure timely reporting of reportable events. Interpret regulations and implement programs to meet these requirements globally. Evaluate and resolve product issues impacting patient safety, escalating as needed. Provide leadership in quality, technical, and compliance matters. Represent the division during audits and inspections. Implement quality metrics to streamline processes and collect data for management reviews. Collaborate with Medical Products Group to provide metrics and participate in regulatory strategies. Maintain the effectiveness of the quality system. Required Qualifications Bachelor's, Master's, or PhD in a related field. Minimum of 5 years in Quality Systems, Quality Assurance, or Regulatory Affairs. Experience in the medical device industry or a regulated environment. At least 3 years of management or supervisory experience. Preferred Qualifications Experience in Medical Events reporting is highly preferred. Ability to manage multiple tasks and priorities effectively. Strong proficiency in Microsoft Office. Ability to engage others and lead projects. Excellent verbal and written communication skills across organizational levels. Ability to multitask, prioritize, and meet deadlines. Strong organizational, follow-up skills, and attention to detail.

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