Medical Events Section Manager
7 days ago
Abbott Laboratories 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.
Job Summary
We are seeking a highly skilled Medical Events Section Manager to join our team. The successful candidate will be responsible for providing direct supervision and management to staff responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products.
Key Responsibilities
- Responsible for scheduling day-to-day activities of medical events group staff to ensure timely review of medical event files.
- Ensures potentially reportable complaints are assessed against criteria for reportability and reports are filed as necessary in compliance with regulations.
- Works closely with Customer Service, Complaint Handling, and Complaint Investigation teams to ensure that the appropriate information is obtained from complainants to make sure an accurate and timely assessment of reportability is made.
- Establishes processes and procedures for medical event reporting within the framework of the complaint handling system.
- Utilizes good judgment and makes timely decisions considering the facts and data at hand; champions specific projects; knows when to escalate to management.
- Actively recruits, interviews and participates in the hiring process of Medical Events Group members.
- Participates as a team member and team leader to monitor the productivity of the group, set priorities, and shift resources as appropriate to meet department goals.
- Sets standards and monitors staff performance; establishes the motivational climate and productivity goals for the group; provides performance feedback; writes and conducts appraisals for employees.
- Assists in development of development and training plans.
- Coordinates changing priorities and organizes process improvement projects.
- Uses tools effectively to monitor progress and results.
Requirements
- Bachelors Degree (± 16 years) or an equivalent combination of education and work experience.
- Knowledge and experience of Quality Systems Regulations (21CFR820), as well as, Medical Device Reporting (21CFR803) and ISO standard.
- Requires experience with complaint handling (21CFR).
- Minimum 5 years In the medical device field.
- Minimum 3 years Management, supervisory or team leadership experience required.
About Abbott Laboratories
Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. We offer a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits. If you are a motivated and experienced professional looking for a challenging opportunity, please submit your application.
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