Senior EU MDR Compliance Lead - Medical Devices

Oracle; Lincoln (NE); Vor Ort; USD 74.000 - 148.000; Vollzeit

Benefits dieser Stelle

Health insurance

Paid time off

401(k) plan

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. The role includes conformity assessment, technical documents, and risk management to enable market access.

You will coordinate audits, CAPA, and monitor regulatory changes while collaborating with suppliers and internal teams to uphold quality objectives. Strong communication and project management are essential.

Qualifikationen

• 5+ years of relevant quality/compliance experience.
• BA/BS or advanced degree preferred.
• Understanding of quality management system standards and risk management.
• Excellent written and verbal communication skills.
• Strong project management skills.
• Ability to adapt to changing priorities in a dynamic environment.

Aufgaben

• Conformity assessment procedures, technical documentation preparation, medical device file development and maintenance.
• Risk management and post-market surveillance for market access.
• Coordinate and assist with internal and external audits, including Notified Body audits for CE marking.
• Support supplier quality management activities and monitor changing European regulatory requirements.
• Act as a subject matter expert on EU market authorization and analyze HQMS data for reporting.

Kenntnisse

Quality management

Risk management

Project management

Communication

Adaptability

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. The role includes conformity assessment, technical documents, and risk management to enable market access.

You will coordinate audits, CAPA, and monitor regulatory changes while collaborating with suppliers and internal teams to uphold quality objectives. Strong communication and project management are essential.