Supervisor, Medical Events Group
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 the Supervisor, Medical Events Group you will be responsible for providing direct supervision to individuals in the Medical Events Group (MEG). Supervision includes answering routine complaint handling questions from individuals in MEG, training, and monitoring complaint cases to ensure timely review, proper documentation, and on time filing of vigilance reports globally. The role will work closely with Customer Service, Complaint Evaluations Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.
This role will ensure the Medical Events Group (MEG) is compliant with global medical device reporting regulations.
What You’ll Work On
- Responsible for supervising personnel who review potentially reportable complaints and file Vigilance Reports to Competent Authorities globally.
- Responsible for ensuring Vigilance Reports are completed and submitted in a timely matter in accordance with applicable regulations and procedures by the Medical Events Group personnel.
- Responsible for working with Customer Service, Complaint Handling Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.
- Responsible for providing subject matter expertise, guidance, and training to members of the Medical Events Group, as well as to other functional departments.
- Responsible for monitoring internal metrics and processes with an eye towards resolving issues and improving the efficiency of the medical events reporting process.
- Responsible for identifying adverse trends found with the medical event process and alerting leadership in a timely manner.
- Support verification of data compiled for metrics, risk evaluations, CAPAs and various other related activities.
- Perform analysis and reporting of metrics for key regulatory and quality forums, including Management Reviews, ensuring accuracy, completeness and timeliness.
- Support cross-functional continuous improvement initiatives involving automation and system enhancements to drive operational efficiency and scalability.
Required Qualifications
- Bachelors Degree in Science, Medical field or equivalent in a technical discipline.
- 4+ years of relevant professional experience, including demonstrated ability to lead projects, influence cross-functional teams, or mentor others; formal people management experience is a plus but not required.
Preferred Qualifications
- Demonstrates initiative, problem-solving, and critical-thinking skills. Strong written and verbal communication skills.
- Knowledge of FDA/International guidelines for drug/device safety reporting requirements.
Apply Now
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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
$100,000.00 – $200,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:ADC Diabetes Care
LOCATION:United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
