JOB DESCRIPTION: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 NowLearn 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.
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)
