Overview

In this role you will leverage clinical expertise to support product quality and patient safety across the product lifecycle. You will partner with multiple teams to influence decision-making and drive regulatory-compliant risk assessments. You will provide clinical interpretation for complaints, investigations, and regulatory submissions, and develop clinically focused training for staff. You contribute to cross-functional audits and process improvements, shaping how groundbreaking cardiovascular technologies reach patients worldwide.

Responsabilidades

- Provide clinical guidance to complaint staff and engineers for event interpretation, investigations, coding, regulatory reporting, and closure.
- Author or review complaint conclusions and communications for complex cases.
- Evaluate information from clinical stakeholders to support investigations and resolve complex cases.
- Interpret imaging related to cardiovascular imaging (e.g., Echo, Fluoroscopy, CT) for clinical input.
- Contribute clinical input to Product Risk Assessments and support decision rationale matrices and related evaluations.




- Develop and deliver clinically based training on anatomy, conditions, products, and event interpretation.
- Review regulatory submissions or ad hoc clinical analyses and communicate findings to internal stakeholders.
- Participate as clinical SME in cross-functional discussions and audits; identify opportunities for process improvement and standardization.
- Perform/interpret additional clinical activities using clinical data, literature, and records as needed.

Requisitos principales

- Bachelor's Degree or Equivalent in a related field
- 5 years of experience in Medical Device industry, quality system, or clinical environment (cardiac care, ICU, OR, or cardiovascular interventions)
- Moderate knowledge of cardiovascular imaging principles and concepts

- facilitation and presentation
- excellent communication
- interpersonal relationship and stakeholder management
- Power BI
- Power Automate
- AI knowledge

📌 Product Quality Clinician (Imaging) - barcelona
🏢 Edwards Lifesciences
📍 Barcelona