Senior EU MDR Compliance Lead - Medical Devices

Oracle; Pierre (SD); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Disability insurance

Life insurance

401(k) with company match

Paid time off

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 and EU MDR requirements. The role involves conformity assessment, documentation, risk management, and post-market surveillance for market access.

Responsibilities include coordinating Notified Body audits, managing CAPA, and monitoring evolving European regulations while collaborating with teams to meet quality objectives and deliver

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 in a dynamic environment.

Responsibilities

• Provide quality system guidance through conformity assessment procedures and technical documentation preparation.
• Develop and maintain medical device files; manage risk management and post-market surveillance for market access.
• Assist with CE marking activities and EU MDR compliance; coordinate Notified Body audits.
• Support internal/external audits and CAPA activities; monitor compliance with regulatory requirements.

Skills

Quality management

Regulatory compliance

CAPA

Audits

Risk management

Cross-functional

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 and EU MDR requirements. The role involves conformity assessment, documentation, risk management, and post-market surveillance for market access.

Responsibilities include coordinating Notified Body audits, managing CAPA, and monitoring evolving European regulations while collaborating with teams to meet quality objectives and deliver