Pmq Clinical Specialist 1 Cr

Título del trabajo: Pmq Clinical Specialist 1 Cr

Compañía: Hologic

Descripción de funciones: Education / Educación: University Bachelor’s degree in physicians, nurses, and biomedical engineers or related career.
Experience / Experiencia: No previous experience required.
Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14971, EU MDR and any related ISO and AAMI standards.
Statistics.
Languages ??required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish/English (Advanced level) Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: Microsoft Office Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades: Assess Potential Adverse Events as per the corresponding regulations and procedures.
Submit Adverse Events/Serious Injuries and follow up reports in accordance with the applicable procedures and on a timely manner.
Follow-up with the end users and any internal department (as Tech Support) for any additional information to Adverse Event/Serious injuries reporting.
Ensure Good Faith Efforts made to the customer are completed and documented in a timely manner within Hologic’s QMS.
Submit Adverse Events/Serious Injuries reports when a MedWatch or any other notification is received (from Notified Bodies, Regulatory Agencies and other sources as PSURs).
Ensure customer communications (as applicable) are created and issued in a timely manner.
Ensure metrics and indicators related to adverse events/serious injuries reporting are under control.
Support complaint handling for products manufactured by Hologic and OEMs/CMs, as required.
Provide support to any response to Regulatory Agencies when follow up questions are submitted to Hologic.
Make decisions based on a risk thinking and Risk Management Files.
Support investigations such as NCEs, CAPAs, IACAs and/or similar.
Ensure they are performed on time, in compliance with procedures and regulations.
Participate in Internal and External Audits/Inspections and Assessments as needed.
Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance’s requirements.
Support the implementation of EHS programs to ensure people safety and environment health.

Ubicación: Alajuela

Fecha del trabajo: Mon, 28 Oct 2024 23:40:35 GMT


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