Remote Clinical Quality Specialist – Cardiovascular Devices

Edwards Lifesciences Gruppe; Dublin; Remote; EUR 90,000 - 110,000; Full time

Job summary

Edwards Lifesciences in Ireland (Remote-friendly) is seeking a Clinical Quality Specialist to provide expert clinical guidance across product life cycles and support regulatory submissions. You will collaborate with complaint staff, engineers, physicians, and other stakeholders to ensure safe, effective medical device performance worldwide.

The role emphasizes interpreting imaging data, training teams, and driving continuous quality improvements while navigating global regulatory expectations.

Qualifications

• Bachelor's Degree or Equivalent in related field, 5 years' of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (i.e. cardiac care, ICU, OR, or cardiovascular/endovascular interventions)
• Moderate knowledge and understanding of principles, theories, and concepts relevant to cardiovascular imaging

Responsibilities

• Provide clinical guidance to complaint staff and engineers on event interpretation, regulatory reporting, and complaint closure.
• Author and/or review complaint conclusions/closure statements and customer communications, including complex or novel cases.
• Evaluate information from clinical specialists, sales staff, physicians, nurses, and other hospital staff to support investigation and drive complex cases toward resolution.
• Evaluate simple and complex imaging such as Echo, Fluoroscopy, CT Scan related to cardiovascular imaging
• Provide clinical input to Product Risk Assessments and support decision matrices and related evaluations.
• Develop and deliver clinically based training to complaint staff and engineers on anatomy, medical conditions, products, procedures, and internal policies.
• Review regulatory submissions, regulatory agency requests, or ad hoc clinical analyses.
• Communicate clinical conclusions, complaint data, trends, and patient-risk information to internal stakeholders; participate as clinical SME in cross-functional discussions and audits.
• Perform and/or provide clinical interpretation for additional complaint-related activities, including review of records, literature, images, or other data.
• Identify and support process improvement opportunities, clinical standardization activities, and development or revision of procedures, tools, and training materials.

Skills

Clinical expertise

Regulatory knowledge

Project management

Communication skills

Education

Bachelor's Degree

Tools

Power BI

Power Automate

Excel

QMS

Job description

Edwards Lifesciences in Ireland (Remote-friendly) is seeking a Clinical Quality Specialist to provide expert clinical guidance across product life cycles and support regulatory submissions. You will collaborate with complaint staff, engineers, physicians, and other stakeholders to ensure safe, effective medical device performance worldwide.

The role emphasizes interpreting imaging data, training teams, and driving continuous quality improvements while navigating global regulatory expectations.