Regulatory Medical Events Specialist I

Abbott Laboratories; Alameda (CA); On-site; USD 82,000 - 141,000; Full time

Benefits offered by this job

Free medical coverage

Tuition reimbursement

Retirement savings plan

Education benefits

Job summary

Abbott Laboratories in Alameda, CA, is seeking a Medical Events Group Specialist I to review medical complaints, assess reportability, and ensure timely regulatory reporting. The role entails documenting rationale, coordinating with cross-functional teams, and staying updated on evolving regulatory requirements within Abbott’s Diabetes Care division.

Ideal candidates hold a Bachelor's degree with at least 1 year in regulatory or quality roles, and demonstrate strong communication, problem

Qualifications

• Bachelor's Degree in related field or an equivalent combination of education and work experience.
• Minimum of 1 year of experience in Regulatory, Medical Events reporting or Quality.

Responsibilities

• Review medical complaints and determine reportability per regulations.
• Document filing rationale in the Complaint Handling System.
• Ensure timely submission of reportable medical events and malfunctions to regulators.
• Monitor status of vigilance reports and complete follow-up actions.
• Collaborate with customer service, complaint evaluation group and investigation teams.
• Provide feedback to promote accurate documentation of cases.
• Stay updated on regulatory requirements and Quality System procedures.
• Adapt processes to updated regulations.

Skills

Regulatory reporting

Quality assurance

Communication

Team collaboration

Education

Bachelor's degree

Job description

Abbott Laboratories in Alameda, CA, is seeking a Medical Events Group Specialist I to review medical complaints, assess reportability, and ensure timely regulatory reporting. The role entails documenting rationale, coordinating with cross-functional teams, and staying updated on evolving regulatory requirements within Abbott’s Diabetes Care division.

Ideal candidates hold a Bachelor's degree with at least 1 year in regulatory or quality roles, and demonstrate strong communication, problem