Clinical Quality Specialist - Cardiac Imaging & Compliance

Edwards Lifesciences Belgium; Madrid; A distancia; EUR 90.000 - 110.000; Jornada completa

Descripción de la vacante

Edwards Lifesciences is seeking a medical device quality specialist to provide clinical guidance, lead complaint investigations, and ensure regulatory reporting across product lifecycles.

You will collaborate with engineers, manufacturing, and product safety, develop training, and contribute to process improvements and risk assessments. A Bachelor's degree and 5 years' related experience are required. Remote work options available.

Formación

• Bachelor's degree in a related field, with 5 years' experience in Medical Device Industry or hospital/clinical quality environment.
• Moderate knowledge of cardiovascular imaging principles.

Responsabilidades

• Provide clinical guidance to complaint staff and engineers on event interpretation, investigation, coding, regulatory reporting, and closure.
• Author or review complaint conclusions and customer communications, including complex cases.
• Evaluate information from clinical staff to support investigations and drive resolution of complex cases.
• Provide clinical input to product risk assessments and support regulatory decision rationale matrices.
• Develop and deliver clinically based training on anatomy, conditions, products, procedures, and policies.
• Review regulatory submissions or agency requests and perform ad hoc analyses.
• Communicate clinical conclusions and trends to internal stakeholders and participate as clinical SME in cross-functional audits.
• Identify opportunities for process improvement and update procedures, tools, and training materials.

Descripción del empleo

Edwards Lifesciences is seeking a medical device quality specialist to provide clinical guidance, lead complaint investigations, and ensure regulatory reporting across product lifecycles.

You will collaborate with engineers, manufacturing, and product safety, develop training, and contribute to process improvements and risk assessments. A Bachelor's degree and 5 years' related experience are required. Remote work options available.