Quality & Regulatory / Post-Market Surveillance

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

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.

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.

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.

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.