EU MDR & CE Medical Device Compliance Lead

Oracle; Sacramento (CA); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical insurance

Paid time off

Employee benefits package

Job summary

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams in medical device quality system compliance, with emphasis on CE marking under EU MDR. You will support conformity assessments, document development, risk management, and post-market activities.

You will collaborate on audits, monitor regulatory changes, and serve as a subject matter expert for EU market access while contributing to supplier quality and HQMS data analysis.

Qualifications

• 5+ years of relevant experience
• BA/BS or advanced degree preferred
• Understanding of quality management system standards and risk management
• Excellent written and verbal communication skills
• Project management skills
• Ability to adjust and adapt to changing priorities

Responsibilities

• Provide quality system support through conformity assessment procedures, technical documentation preparation, and medical device file development and maintenance
• Perform risk management and post-market surveillance for market access
• Coordinate and assist with internal and external audits, including Notified Body audits related to CE marking
• Help monitor compliance with evolving European regulatory requirements and act as a SME on EU market authorization
• Analyze HQMS data and metrics for management reporting and support supplier quality management activities

Job description

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams in medical device quality system compliance, with emphasis on CE marking under EU MDR. You will support conformity assessments, document development, risk management, and post-market activities.

You will collaborate on audits, monitor regulatory changes, and serve as a subject matter expert for EU market access while contributing to supplier quality and HQMS data analysis.