Senior EU MDR Compliance Lead for Medical Devices

Oracle; Oklahoma City (OK); 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 emphasis on EU MDR and CE marking processes.

Responsibilities include conformity assessment, technical documentation, risk management, CAPA, and post-market surveillance to support US and international market access. Strong collaboration with internal partners and auditors is required.

Qualifications

• 5+ years of relevant experience
• BA/BS or advanced degree preferred
• Have an 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 in a dynamic environment.

Responsibilities

• Provide quality system support through conformity assessment procedures and technical documentation preparation.
• Maintain medical device file development and CAPA processes.
• Coordinate internal and external audits, including Notified Body audits related to CE marking.

Skills

Quality management

Risk management

Project management

Written and verbal communication

Adaptability

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, with emphasis on EU MDR and CE marking processes.

Responsibilities include conformity assessment, technical documentation, risk management, CAPA, and post-market surveillance to support US and international market access. Strong collaboration with internal partners and auditors is required.