Senior Specialist - Medical Events Group

Senior Specialist – Medical Events Group 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. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO 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 This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As Medical Events Group Senior Specialist, you will be responsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products. What You’ll Work On Review medical complaints and potentially reportable events, gather required additional information to determine the reportability of the complaint in accordance with regulations. Document filing decision rationale in the Complaint Handling System. Ensure timely submission of reportable medical events and malfunctions to regulatory authorities in accordance with local and international regulations. Monitor the status of submitted vigilance reports and ensure follow‑up actions are completed in timely manner. Collaborate with internal teams such as customer service, Complaint evaluation group and complaint investigation team to gather necessary information for vigilance reports. Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case. Adapt processes and documentation to align with updated regulations. Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis. Demonstrates subject matter expertise; provide guidance, and training to other members of the Medical Events Group as well as to other functional departments. Drive improvements to standard operating procedures, training and other tools used by for the Medical Events Group as required. Required Qualifications Bachelors Degree in related field or an equivalent combination of education and work experience; Associates Degree with minimum 8 yrs of industry experience will also be accepted Minimum of 5 years of experience in Regulatory experience required. Preferred Qualifications Ability to communicate at all levels with clarity and precision both written and verbally. Excellent problem‑solving and critical‑thinking skills. Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Multitasks, prioritizes and meets deadlines in timely manner. Divisional Information Medical Devices Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. CRM As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. Diabetes We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Vascular Abbott Vascular provides innovative, minimally invasive, and cost‑effective products for the treatment of vascular disease. Neuromodulation Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non‑opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Structural Heart Structural Heart Business Mission : Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. EP In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. HF In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. Diagnostics We’re empowering smarter medical and economic decision‑making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision‑making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. Our molecular division delivers best‑in‑class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular‑based solutions. Nutrition Our nutrition business develops science‑based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at on Facebook at and on Twitter @AbbottNews. The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr RXinsider LTD.