EU MDR Compliance Lead - Medical Devices

Oracle; Springfield (IL); Vor Ort; USD 74.000 - 148.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

Paid time off

401(k) Savings with company match

Paid parental leave

Sick leave

Zusammenfassung

Oracle Health seeks 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, create and maintain technical documentation, manage risk, and oversee post-market surveillance.

You will coordinate internal and external audits, including Notified Body audits, and stay current with European regulatory changes.

Qualifikationen

• 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.

Aufgaben

• Provide quality system support through conformity assessment procedures and technical documentation preparation.
• Develop and maintain medical device files; manage risk and post-market surveillance.
• Coordinate internal and external audits, including Notified Body audits for CE marking.
• Assist in monitoring compliance with evolving European regulatory requirements; act as SME on EU market authorization.
• Analyze HQMS data and metrics for management reporting; support supplier quality management.

Kenntnisse

Excellent communication

Project management

Adaptability

Quality management knowledge

Ausbildung

BA/BS or higher

Jobbeschreibung

Oracle Health seeks 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, create and maintain technical documentation, manage risk, and oversee post-market surveillance.

You will coordinate internal and external audits, including Notified Body audits, and stay current with European regulatory changes.