EU MDR Compliance Lead for Medical Devices

Oracle; Carson City (NV); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Disability insurance (short/long term)

Life insurance

401(k) plan with company match

Paid time off & holidays

Parental leave & adoption assistance

Stock Purchase Plan

Flexible Spending Accounts

Commuter benefits

Job summary

Oracle Health in the United States seeks a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking and EU MDR requirements. You will prepare technical documentation, manage risk, and oversee post-market surveillance for market access.

The role collaborates with internal and external auditors, including Notified Bodies, and supports CAPA, monitoring regulatory changes and acting as a subject matter expert on EU market

Qualifications

• 5+ years of relevant experience
• Understanding of quality management system standards and risk management
• Excellent written and verbal communication skills
• Project management skills
• Ability to adapt to changing priorities

Responsibilities

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

Skills

5+ years experience

BA/BS or advanced degree

QMS and risk management

Excellent communication

Project management

Adaptability

Education

BA/BS or advanced degree

Job description

Oracle Health in the United States seeks a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking and EU MDR requirements. You will prepare technical documentation, manage risk, and oversee post-market surveillance for market access.

The role collaborates with internal and external auditors, including Notified Bodies, and supports CAPA, monitoring regulatory changes and acting as a subject matter expert on EU market