EU MDR & CE Mark Compliance Lead (Medical Devices)

Oracle; Cheyenne (WY); Vor Ort; USD 74.000 - 148.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Paid time off

401(k) contribution

Zusammenfassung

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, with emphasis on CE marking under EU MDR. The role focuses on conformity assessment, technical documentation, and risk management to enable market access.

Responsibilities include audits coordination, CAPA, and maintaining up‑to‑date regulatory knowledge, with collaboration across departments and supplier quality management.

Qualifikationen

• 5+ years of relevant experience in quality/compliance roles.
• 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.
• Develop and maintain medical device files, manage risk, and post-market surveillance for market access.
• Coordinate internal and external audits including Notified Body audits for CE marking.
• Assist with regulatory changes and act as SME on EU market authorization.
• Monitor HQMS data and support supplier quality management.

Kenntnisse

5+ years experience

Excellent communication

Project management

Adaptability

Ausbildung

BA/BS or higher

Tools

QA standards

Jobbeschreibung

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, with emphasis on CE marking under EU MDR. The role focuses on conformity assessment, technical documentation, and risk management to enable market access.

Responsibilities include audits coordination, CAPA, and maintaining up‑to‑date regulatory knowledge, with collaboration across departments and supplier quality management.