Medical Events Group Specialist I

RXinsider LTD.; Alameda, Northern (CA, KY); Hybrid; USD 82,000 - 141,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Education benefits

Diversity recognition

Job summary

Abbott in Alameda, CA is seeking a Medical Events Group Specialist I to review medical complaints, determine reportability, and ensure timely submission to regulatory authorities as required by local and international regulations.

The role collaborates with customer service and quality teams to gather information, document rationale, and maintain vigilance records, while staying current with regulatory requirements and quality procedures for ongoing process improvements.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Minimum 1 year of experience in regulatory, medical events reporting or quality.

Responsibilities

• Review medical complaints and determine reportability per regulations.
• Document reasoning in the Complaint Handling System.
• Ensure timely submission of reportable medical events and malfunctions to authorities.
• Monitor status of submitted vigilance reports and complete follow-up actions.
• Collaborate with customer service, complaint evaluation and investigation teams to gather information.
• Provide feedback to promote accurate documentation within the Quality team.
• Stay updated on regulatory requirements and quality system procedures.
• Adapt processes and documentation to regulatory changes.
• Interface with management to ensure timely PREs are obtained.

Skills

Regulatory knowledge

Medical events reporting

Quality systems

Education

Bachelor's degree or equivalent

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.

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.

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 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.

The base pay for this position is $81,500.00 – $141,300.00. In specific locations, the pay range may vary from the range posted.