Senior EU MDR Compliance Lead – Medical Devices

Oracle; Raleigh (NC); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Paid time off

401(k) with company match

Paid holidays

Job summary

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, with a focus on EU MDR CE marking, conformity assessment, and technical documentation.

You will maintain up-to-date knowledge of EU regulations, coordinate Notified Body audits, manage CAPAs, and support supplier quality management across the EU market access.

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 in a dynamic environment.

Responsibilities

• Provide quality system support through conformity assessment procedures, technical documentation preparation, medical device file development and maintenance, risk management, and post-market surveillance for medical device market access.
• Coordinate internal and external audits, including Notified Body audits related to CE marking, and help manage corrective and preventive actions (CAPA).
• Assist with monitor compliance with changing European regulatory requirements and act as a subject matter expert on EU market authorization.
• Maintain up-to-date knowledge relevant regulations, work with cross-functional teams to meet quality objectives, analyze HQMS data and metrics for management reporting, and support supplier quality management activities.

Skills

Quality management systems

Risk management

Regulatory compliance

Project management

Communication skills

Education

BA/BS or advanced degree preferred

Job description

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, with a focus on EU MDR CE marking, conformity assessment, and technical documentation.

You will maintain up-to-date knowledge of EU regulations, coordinate Notified Body audits, manage CAPAs, and support supplier quality management across the EU market access.