Clinical Validation Specialist

Philips
Suzhou
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 7+ yearsEducation: mastersSkills: ["Organization","Coordination","Leadership","Communication","Documentation"]

Drive clinical validation for CT products from an end-user (doctor/technician) perspective by executing clinical workflows in simulated or real environments. Own design validation plans, protocols, and reports, coordinate internal/external validation activities, and serve as an SME during audits. Prepare English documentation, conduct image review and clinical feedback risk analysis, manage validation traceability and evidence for regulatory bodies, and translate clinical site issues into tracked defects.

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FursaFursa
Philips
Philips
2 months ago

Clinical Validation Specialist

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Source: Company careers pageValidated by: Fursa AI
Last checked: 27 days agoStatus: Live

Job Summary

Drive clinical validation for CT products from an end-user (doctor/technician) perspective by executing clinical workflows in simulated or real environments. Own design validation plans, protocols, and reports, coordinate internal/external validation activities, and serve as an SME during audits. Prepare English documentation, conduct image review and clinical feedback risk analysis, manage validation traceability and evidence for regulatory bodies, and translate clinical site issues into tracked defects.
Location: Suzhou
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Execute clinical workflows to test and validate CT systems in simulated or real clinical environments.
  • •Own design validation planning and reporting, including defining entry/exit criteria and coordinating validation activities.
  • •Prepare and maintain validation documentation in English, and participate in peer review of design documents.
  • •Provide clinical expert input on CT workflow, image quality, and clinical performance needs to R&D, including independent image review observations/feedback.
  • •Generate validation evidence and traceability for regulatory bodies (FDA, NMPA, CE, etc.), translate clinical site issues into defects, and train clinical validation sites.

Key Requirements

  • •Master’s degree in Radiology/Radiography or higher.
  • •Professional license certification as a Radiologist or Radiographer.
  • •7+ years hospital imaging diagnosis/imaging analysis experience.
  • •10+ years radiography technology experience including work with CT systems.
  • •Proficient written and spoken English; strong organizational skills for leading and coordinating validation activities.
Experience:7+ yearsRadiologyMedical imagingHospital
Education:Master's in Radiology/Radiography
Skills:OrganizationCoordinationLeadershipCommunicationDocumentation
Certifications:RadiologistRadiographer
Languages:English
Tech Stack:CTDesign validation planDesign validation protocolDesign validation reportDesign Validation Traceability MatrixQMSPDLMRisk analysisFDANMPACEDefect management toolImage reviewAI

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn