Senior EU MDR Compliance Lead – Medical Devices

Oracle; Topeka (KS); 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, focusing on EU MDR requirements and CE marking processes.

The role involves conformity assessment procedures, technical documentation, risk management, and post-market surveillance, with exposure to Notified Body audits and CAPA management. Strong written and verbal communication and project coordination are essential.

Qualifications

• 5+ years of relevant compliance experience.
• Understanding of quality management system standards and risk management.
• Excellent written and verbal communication skills.
• Project management abilities and cross-functional collaboration.

Responsibilities

• Provide quality system support for conformity assessment procedures and EU MDR requirements.
• Prepare technical documentation and maintain medical device files.
• Perform risk management activities and support post-market surveillance.
• Coordinate and assist with internal and external audits, including Notified Body audits.
• Assist with CAPA management and monitor regulatory changes for EU market authorization.

Skills

Quality management

Risk management

Communication skills

Project management

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, focusing on EU MDR requirements and CE marking processes.

The role involves conformity assessment procedures, technical documentation, risk management, and post-market surveillance, with exposure to Notified Body audits and CAPA management. Strong written and verbal communication and project coordination are essential.