Ultrasound Risk & Post-Market Quality Leader

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO seeks an experienced Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. You will evaluate field issues, complaints, and product non-conformances to ensure patient safety and regulatory compliance.

The role involves risk assessment per ISO 14971, CAPA integration, and cross-functional collaboration with R&D, Quality, and Regulatory Affairs. Prior experience with FDA/EU MDR processes is preferred.

Qualifications

• Experience in medical device risk management and CAPA.
• HHE / product safety evaluation experience.

Responsibilities

• Perform HHE assessments for complaints, field issues and non-conformances.
• Evaluate patient/user risk and determine severity and likelihood.
• Recommend actions such as FSCA, recalls or advisories.
• Partner with CAPA teams on root cause investigations and corrective actions.
• Prepare HHE reports and risk documentation; ensure traceability.
• Support regulatory reporting decisions (FDA, EU MDR).
• Collaborate with R&D, QA, and Regulatory Affairs.

Skills

Analytical thinking

Risk assessment

Documentation & communication

Stakeholder management

Education

Biomedical Engineering / Electronics degree

Job description

Katalyst CRO seeks an experienced Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. You will evaluate field issues, complaints, and product non-conformances to ensure patient safety and regulatory compliance.

The role involves risk assessment per ISO 14971, CAPA integration, and cross-functional collaboration with R&D, Quality, and Regulatory Affairs. Prior experience with FDA/EU MDR processes is preferred.