Senior EU MDR Compliance Lead – Medical Devices

Oracle; Denver (CO); Vor Ort; USD 74.000 - 148.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision insurance

401(k) with company match

Paid time off

Zusammenfassung

Oracle Health seeks a Senior Compliance Specialist to guide cross-functional teams on EU MDR compliance, supporting CE marking, conformity assessment, and medical device file maintenance. The role involves risk management, post-market surveillance coordination, and alignment with evolving European regulations.

Candidate will work with QA, regulatory, and operations to ensure robust quality systems, assist with audits, and monitor regulatory changes affecting market access across Europe.

Qualifikationen

• 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 risk management artifacts.
• Support CAPA activities and audits, including Notified Body audits for CE marking.
• Monitor regulatory requirements and advise cross-functional teams on EU market authorization.

Kenntnisse

Quality management

Risk management

Project management

Regulatory compliance

Written & verbal communication

Ausbildung

BA/BS or higher

Jobbeschreibung

Oracle Health seeks a Senior Compliance Specialist to guide cross-functional teams on EU MDR compliance, supporting CE marking, conformity assessment, and medical device file maintenance. The role involves risk management, post-market surveillance coordination, and alignment with evolving European regulations.

Candidate will work with QA, regulatory, and operations to ensure robust quality systems, assist with audits, and monitor regulatory changes affecting market access across Europe.