Quality & Regulatory / Post-Market Surveillance

About the role

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.
• 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).

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.