Senior Regulatory Compliance Specialist Medical Device

Oracle Oracle · Enterprise · United States

This role focuses on regulatory compliance for medical devices within Oracle Health, specifically concerning EU MDR and CE marking processes. The specialist will provide quality system support, manage technical documentation, risk management, and post-market surveillance, and assist with audits and CAPA. The role requires expertise in quality management system standards and risk management, with a focus on European regulatory requirements for market access.

What you'd actually do

  1. Provides guidance to cross-functional teams on medical device quality system compliance, with a focus on quality system support for CE marking processes and requirements under the EU Medical Device Regulation (EU MDR).
  2. Provide quality system support through conformity assessment procedures, technical documentation preparation, medical device file development and maintenance, risk management, and post-market surveillance for medical device market access.
  3. Coordinates and assist with both internal and external audits, including Notified Body audits related to CE marking, and helps manage corrective and preventive actions (CAPA).
  4. Assists with monitor compliance with changing European regulatory requirements and act as a subject matter expert on EU market authorization.
  5. Maintains up-to-date knowledge relevant regulations, works collaboratively with cross-functional teams to meet quality objectives, analyses HQMS data and metrics for management reporting, and supports supplier quality management activities.

Skills

Required

  • 5 plus years of relevant experience
  • 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

Nice to have

  • BA/BS or advanced degree preferred

What the JD emphasized

  • medical device quality system compliance
  • EU Medical Device Regulation (EU MDR)
  • CE marking processes
  • quality system support
  • technical documentation preparation
  • medical device file development and maintenance
  • risk management
  • post-market surveillance
  • internal and external audits
  • Notified Body audits
  • corrective and preventive actions (CAPA)
  • European regulatory requirements
  • EU market authorization
  • quality management system standards
  • risk management