EU MDR Compliance Lead – Medical Device Quality & Equity

Oracle; Tallahassee (FL); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) Savings and Investment Plan

Paid time off

Employee Stock Purchase Plan

Paid parental leave

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, document development, risk management, and post-market surveillance to enable EU market access.

You will coordinate audits, assist with CAPA, monitor regulatory changes, and act as an SME on EU requirements while collaborating with suppliers and internal teams.

Qualifications

• 5+ years of relevant experience in quality systems and regulatory compliance.
• Understanding of quality management system standards and risk management.
• Excellent written and verbal communication skills.
• Project management skills and ability to handle multiple priorities.

Responsibilities

• Provide quality system support through conformity assessment procedures and technical documentation preparation.
• Develop and maintain medical device files, conduct risk management, and oversee post-market surveillance for market access.
• Coordinate internal and external audits, including Notified Body audits related to CE marking.
• Assist with regulatory changes and act as SME on EU market authorization.
• Monitor HQMS data and metrics for management reporting; support supplier quality management.

Skills

Quality management

Regulatory understanding

Communication skills

Project management

Education

BA/BS or advanced 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, document development, risk management, and post-market surveillance to enable EU market access.

You will coordinate audits, assist with CAPA, monitor regulatory changes, and act as an SME on EU requirements while collaborating with suppliers and internal teams.