Analista Senior de Calidad y Cumplimiento Regulatorio SLA

at  Abbott Laboratories

REQUIRED QUALIFICATIONS

Bachelor’s degree Biomedical Engineering, Pharmaceutical Chemistry, Industrial engineering, or related areas

PREFERRED QUALIFICATIONS

• 3 year of experience
• Fluent in English
• Técnica knowledge on medical devices and equipment
• Teamwork
• MS Office
• Power BI

Interact and communicate with Sales Reps and Distributor contacts to ensure timely PER submission and responses to Request for Information (RFI).

• Prepare and submit serious adverse event and quarterly reports to regulatory authorities according to post-market surveillance regulation.
• Close follow-up and communication with the Product Performance Group (PPG) to obtain PERs analysis information and guarantee accurate understanding of data provided in Spanish by Sales Reps. and Regional Distributors contacts.
• Collection, analysis and reporting of applicable KPI to upper management and distributor’s representative in a periodic basis.
• Coordinate and ensure the prompt return of devices involved in PERs for investigation and analysis.
• Maintain and update South and Central LATAM AV and SH PERs databases to provide information to Regulatory Authorities and stakeholders in a timely manner.
• Support the process of non-conformities identification and corrective and preventive actions (CAPA) implementation to pursue the Quality System continuous improvement.
• Perform control of South and Central America Distributors processes to confirm compliance with Abbott and Divisional policies and procedures.
• Contribute to the Quality Management System (QMS) documents creation, review and update to comply with the defined requirements and optimize processes.
• Support the product approval and sales release process.
• Execute Quality Control tasks as a member of the SLA Quality Team
• Support activities for Quality Improvement Projects by executing tasks as assigned or follow-up on actions in Quality Plans.
• Ensure training compliance within SLA region related to product experience handling, through on-line trainings.
• Support CALA QS Manager with monthly & quarterly consolidation of Key Performance Indicators (KPI) as indicated on the LS608 Quality System Metric Definition. In addition, active participation at the Division COMQA Escalation review. The responsibilities will be carried out temporarily until the return of CALA Sr. QA Analyst.