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Medical Events Specialist I

Abbott

Alameda, CA, US$82k – $141konsite

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About this role

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Medical Events Group Specialist I

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 Specialist I, 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. • Stay updated on regulatory requirements, internal Quality System procedures and guidelines related to medical device vigilance reporting. • 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.

Required Qualifications • Bachelors Degree in related field or an equivalent combination of education and work experience • Minimum of 1 year of experience in Regulatory, Medical Events reporting or Quality.

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.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:    www.abbottbenefits.com 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   www.abbott.com, on Facebook at   www.facebook.com/Abbott, and on Twitter @AbbottNews.

Divisional Information Medical Devices General 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 develop

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