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.