Supervisor, Medical Events Group at Abbott

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 115,000 colleagues serve people in more than 160 countries.

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.

Responsibilities include:

• Supervising personnel who review potentially reportable complaints and file Vigilance Reports to Competent Authorities globally.
• Ensuring Vigilance Reports are completed and submitted in a timely manner in accordance with applicable regulations and procedures by the Medical Events Group personnel.
• Working with Customer Service, Complaint Handling Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.
• Providing subject matter expertise, guidance, and training to members of the Medical Events Group, as well as to other functional departments.
• Monitoring internal metrics and processes with an eye towards resolving issues and improving the efficiency of the medical events reporting process.
• Identifying adverse trends found with the medical event process and alerting leadership in a timely manner.
• Supporting verification of data compiled for metrics, risk evaluations, CAPAs and various other related activities.
• Performing analysis and reporting of metrics for key regulatory and quality forums, including Management Reviews, ensuring accuracy, completeness and timeliness.
• Supporting cross-functional continuous improvement initiatives involving automation and system enhancements to drive operational efficiency and scalability.

Required Qualifications include:

• 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 include:

• 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.