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 122,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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 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

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.

     

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:

Not Applicable

     

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)

     

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

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf