Quality & Regulatory / Post-Market Surveillance
Katalyst Healthcares and Life Sciences
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):
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)
- 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.
- 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.
- Ensure alignment with:
- FDA 21 CFR Part 820.
- EU MDR.
- ISO 13485.
- Support audits, inspections, and regulatory submissions.
- Work closely with:
- R&D / Engineering.
- Quality & Regulatory Affairs.
- Clinical and Field teams.
- Provide risk-based input for product changes and issue resolution.
- Prepare HHE reports, risk assessments, and CAPA documentation.
- Ensure traceability across complaints, CAPA, and risk files.
- Maintain audit-ready records.
- Bachelor's or Master's degree in Biomedical Engineering, Electronics, or related field.
- 5-15 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).
- Strong analytical and problem-solving skills.
- bility to assess clinical and technical risks.
- Excellent documentation and communication skills.
- Stakeholder management across global teams.
- Experience with Philips or similar medical device organizations.
- Familiarity with post-market surveillance systems.
- Six Sigma / Quality certifications.
- Understanding of ultrasound imaging technology.
Vacancy posted 1 day ago
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