Quality & Regulatory / Post-Market Surveillance

Summary

Title: Quality & Regulatory / Post-Market Surveillance

Location: Boston MA & Bothell WA

Rate: $55/Hr on C2C

Client: Tata Elxsi | Philips

Role Summary

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.

Key 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

Required Qualifications

• 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

Job Description

Title: Quality & Regulatory / Post-Market Surveillance

Location: Boston MA & Bothell WA

Rate: $55/Hr on C2C

Client: Tata Elxsi | Philips

Role Summary

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.

Key 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

Required Qualifications

• 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