Senior EU MDR Compliance Lead – Medical Devices

Oracle; Des Moines (IA); On-site; USD 74,000 - 148,000; Full time

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 CE marking processes and EU MDR requirements. The role covers conformity assessment, technical documentation, medical device file development, risk management, and post-market surveillance for market access.

The incumbent coordinates audits, supports CAPA, and ensures adherence to evolving European regulations.

Qualifications

• 5+ years of relevant experience in quality/compliance roles.
• Understanding of quality management system standards and risk management.
• Excellent written and verbal communication skills.

Responsibilities

• Provide quality system support through conformity assessment procedures and technical documentation.
• Maintain medical device files, perform risk management and post-market surveillance for market access.
• Coordinate internal and external audits, including Notified Body audits related to CE marking.
• Monitor regulatory changes and act as SME on EU market authorization.

Skills

Quality systems

Communication

Project management

Regulatory compliance

Education

BA/BS or advanced degree preferred

Tools

Notified Body audits

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 CE marking processes and EU MDR requirements. The role covers conformity assessment, technical documentation, medical device file development, risk management, and post-market surveillance for market access.

The incumbent coordinates audits, supports CAPA, and ensures adherence to evolving European regulations.