Quality & Regulatory / Post-Market Surveillance
Katalyst CRO
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. 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. 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. 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). 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. #J-18808-Ljbffr Katalyst CROVacancy posted 2 days ago
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