EU MDR Compliance Lead – Medical Device Quality

Oracle; Santa Fe (NM); Presencial; USD 74 000 - 148 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental, and vision insurance

Disability insurance

Life insurance

401(k) Savings and Investment Plan

Resumo da oferta

Oracle Health seeks a Senior Compliance Specialist to guide cross‑functional teams on medical device quality system compliance, focusing on CE marking and EU MDR requirements. The role covers conformity assessment, documentation, risk management, and post‑market surveillance.

Responsibilities include audits coordination, CAPA, regulatory monitoring, HQMS data analysis, and supplier quality support, with collaboration across the business.

Qualificações

• Bachelor’s degree or higher in a relevant field
• 5+ years of experience in quality/compliance
• Understanding of quality management system standards and risk management
• Excellent written and verbal communication skills
• Project management skills
• Able to adapt to changing priorities in a dynamic environment

Responsabilidades

• Provide quality system support for conformity assessment procedures, technical documentation, and post‑market surveillance
• Coordinate and assist with Notified Body audits (CE marking) and CAPAs
• Monitor compliance with EU regulatory requirements and act as SME for EU market authorization
• Analyze HQMS data and metrics for management reporting
• Support supplier quality management activities

Conhecimentos

5+ years exp

PM skills

Excellent communication

Adaptability

Quality Management System knowledge

Formação académica

BA/BS or higher

Descrição da oferta de emprego

Oracle Health seeks a Senior Compliance Specialist to guide cross‑functional teams on medical device quality system compliance, focusing on CE marking and EU MDR requirements. The role covers conformity assessment, documentation, risk management, and post‑market surveillance.

Responsibilities include audits coordination, CAPA, regulatory monitoring, HQMS data analysis, and supplier quality support, with collaboration across the business.