Quality & Regulatory / Post-Market Surveillance

Katalyst CRO; Bothell (WA); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking a Risk & Health Hazard Evaluation Specialist to support CAPA and post-market activities for ultrasound systems. The role ensures patient safety and regulatory compliance by evaluating field issues, complaints, and non-conformances.

You will perform HHE assessments, lead risk evaluations per ISO 14971, and collaborate with R&D, QA, and field teams to drive effective risk controls and CAPA actions.

Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Electronics, or related field.

Responsibilities

• Perform HHE assessments for complaints, field issues, and non-conformances.
• Evaluate patient/user risk and determine severity and likelihood.
• Support regulatory reporting decisions (FDA, EU MDR).
• Conduct and update risk assessments per ISO 14971.
• Maintain and update Risk Management Files (RMF) and related analyses.
• Partner with CAPA teams on root cause investigations and corrective actions.
• Prepare HHE reports, risk assessments, and CAPA documentation.

Skills

Risk assessment

HHE

CAPA integration

Regulatory affairs

Documentation

Education

Biomedical Engineering

Electronics

Job description

Job Description

We are seeking a skilled Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. This role is critical in ensuring patient safety, regulatory compliance, and effective risk management by evaluating field issues, complaints, and product non-conformances.

We are seeking a skilled Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. This role is critical in ensuring patient safety, regulatory compliance, and effective risk management by evaluating field issues, complaints, and product non-conformances.

Responsibilities

Health Hazard Evaluation (HHE)

• Perform HHE assessments for complaints, field issues, and non-conformances.
• Evaluate patient/user risk and determine severity and likelihood.
• Recommend actions such as Field Safety Corrective Actions (FSCA), recalls, or advisories.
• Support regulatory reporting decisions (FDA, EU MDR).

Risk Management

• Conduct and update risk assessments per ISO 14971.
• Maintain and update:
  • Risk Management Files (RMF).
  • Hazard Analysis, FMEA, Fault Tree Analysis.
  • Ensure risk controls are implemented and residual risks are acceptable.

CAPA Support

• Partner with CAPA teams on root cause investigations and corrective actions.
• Integrate risk evaluation into CAPA lifecycle.
• Perform effectiveness checks and risk reassessment post-implementation.

Regulatory & Compliance

• Ensure alignment with:
  • FDA 21 CFR Part 820.
  • EU MDR.
  • ISO 13485.
• Support audits, inspections, and regulatory submissions.

Cross-Functional Collaboration

• Work closely with:
  • R&D / Engineering.
  • Quality & Regulatory Affairs.
  • Clinical and Field teams.
  • Provide risk-based input for product changes and issue resolution.

Documentation

• Prepare HHE reports, risk assessments, and CAPA documentation.
• Ensure traceability across complaints, CAPA, and risk files.
• Maintain audit-ready records.

Requirements

• Bachelor's or Master's degree in Biomedical Engineering, Electronics, or related field.
• 515 years of experience in:
  • Medical device risk management & CAPA.
  • HHE / product safety evaluation.
• Strong knowledge of:
  • ISO 14971, ISO 13485.
  • FDA and EU MDR regulations.
• Experience with diagnostic imaging systems (Ultrasound preferred).

Key Skills

• Strong analytical and problem-solving skills.
• Ability to assess clinical and technical risks.
• Excellent documentation and communication skills.
• Stakeholder management across global teams.

Preferred / Good to Have

• Experience with Philips or similar medical device organizations.
• Familiarity with post-market surveillance systems.
• Six Sigma / Quality certifications.
• Understanding of ultrasound imaging technology.