Senior EU MDR Compliance Lead – Medical Devices

Oracle; Montgomery (AL); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Short and long-term disability

Life insurance and AD&D

Employee Stock Purchase Plan

Paid time off and holidays

Job summary

Oracle Health seeks 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 assessments, documentation, risk management, and post-market surveillance to enable market access.

You will coordinate internal and external audits, including Notified Body activities, and ensure compliance with evolving European requirements while collaborating with suppliers and teams across the

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.
• Maintain and update risk management files and support post-market surveillance for market access.
• Coordinate internal and external audits, including Notified Body audits related to CE marking.
• Assist with monitoring changes in European regulatory requirements and advise on EU market authorization.
• Collaborate with cross-functional teams and analyze HQMS data for management reporting.

Skills

Quality management

Risk management

Written and verbal communication

Project management

Prioritization in dynamic environments

Education

BA/BS or advanced degree

Job description

Oracle Health seeks 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 assessments, documentation, risk management, and post-market surveillance to enable market access.

You will coordinate internal and external audits, including Notified Body activities, and ensure compliance with evolving European requirements while collaborating with suppliers and teams across the