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).
• Maintain and update 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.
• Ensure alignment with EU MDR.
• Ensure alignment with ISO 13485.
• Support audits, inspections, and regulatory submissions.

Cross-Functional Collaboration

• Work closely with R&D / Engineering.
• Work closely with Quality & Regulatory Affairs.
• Work closely with 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.
• 5–15 years of experience in HHE / product safety evaluation.
• Strong knowledge of ISO 14971, ISO 13485.
• Strong knowledge of 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.