Supervisor, Medical Events Group

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 115000 colleagues serve people in more than 160 countries.

Supervisor 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. Youll 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 bachelors 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 were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were 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 Youll 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full 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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 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

Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were 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 Abbotts Electrophysiology (EP) business were 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 Abbotts Heart Failure (HF) business were developing solutions to diagnose monitor and manage heart failure allowing people to restore their health and get on with their lives.

Diagnostics

Were 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 Abbotts 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 worlds greatest healthcare challenges.

Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to lifes 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

$100000.00 $200000.00

In specific locations the pay range may vary from the range posted.

Regulatory Operations

ADC Diabetes Care

United States > Alameda : 1360-1380 South Loop Road

Standard

No

No

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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Manager