EU MDR Compliance Lead for Medical Devices

Oracle; Juneau (AK); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Health benefits

PTO

401(k) plan

Job summary

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking under EU MDR. You will support conformity assessment procedures, document development, and CAPA, while monitoring regulatory changes and acting as a subject matter expert on EU market authorization.

Ideal candidates have 5+ years in quality/compliance roles, strong communication, and project management skills to drive accurate documentation

Qualifications

• Knowledge of quality management system standards.
• Understanding of risk management.
• Experience with EU MDR requirements and CE marking.

Responsibilities

• Provide quality system support for conformity assessment procedures.
• Prepare technical documentation and medical device files.
• Lead risk management activities and post-market surveillance for market access.
• Coordinate internal and external audits, including Notified Body audits.
• Support CAPA activities and monitor compliance with evolving European regulations.
• Collaborate with cross-functional teams to meet quality objectives.

Skills

Quality management

Regulatory compliance

EU MDR

Project management

Communication skills

Adaptive to change

Education

BA/BS or higher degree

Job description

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking under EU MDR. You will support conformity assessment procedures, document development, and CAPA, while monitoring regulatory changes and acting as a subject matter expert on EU market authorization.

Ideal candidates have 5+ years in quality/compliance roles, strong communication, and project management skills to drive accurate documentation