Quality & Regulatory / Post-Market Surveillance

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.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).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.