EU MDR Compliance Lead - Medical Device Quality

Oracle; Providence (RI); Vor Ort; USD 74.000 - 148.000; Vollzeit

Benefits dieser Stelle

Medical/dental/vision insurance

Paid time off

401(k) with company match

Parental leave

Zusammenfassung

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking under EU MDR. Responsibilities include conformity assessment, technical documentation, and CAPA management.

The role requires strong knowledge of quality management standards, regulatory requirements, and the ability to work with diverse teams to ensure market access and ongoing compliance.

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.
• Develop and maintain medical device files and conduct risk management.
• Support CAPA and post-market surveillance activities.
• Assist audits including Notified Body audits related to CE marking.
• Monitor regulatory changes and act as subject matter expert on EU market authorization.
• Collaborate with cross-functional teams and analyze HQMS data for management reporting.

Kenntnisse

Quality management system knowledge

Excellent communication

Project management

Ability to adapt to changing priority

EU MDR knowledge

Ausbildung

BA/BS or advanced degree

Jobbeschreibung

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking under EU MDR. Responsibilities include conformity assessment, technical documentation, and CAPA management.

The role requires strong knowledge of quality management standards, regulatory requirements, and the ability to work with diverse teams to ensure market access and ongoing compliance.