Senior Regulatory Compliance Specialist Medical Device

Oracle

Actively hiring Posted this week
US Posted 5 days ago $70,600–$141,200 / year
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At a glance

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TL;DR

As a Senior Regulatory Compliance Specialist at Oracle Health, you will join a dedicated team focused on ensuring medical device quality system compliance under the EU Medical Device Regulation (EU MDR). Your role involves providing critical guidance and support for CE marking processes, including technical documentation preparation, risk management, and post-market surveillance. You will coordinate internal and external audits, manage corrective and preventive actions, and ensure adherence to evolving European regulatory requirements. Key responsibilities include maintaining up-to-date knowledge of quality management system standards, collaborating with cross-functional teams, analyzing HQMS data for reporting, and supporting supplier quality management activities. This position requires expertise in CE marking processes, EU regulatory frameworks, ISO 13485 standards, and a strong background in project management and adaptability to dynamic environments.

Skills

CE Marking Process EU Regulatory Frameworks ISO 13485 Standards Quality Management System Regulatory Submissions Internal Audits External Audits CAPA Risk Management Project Management HQMS Data Analysis Supplier Quality Management

What you'll do

  • Provide guidance on medical device quality system compliance for CE marking.
  • Develop and maintain technical documentation and medical device files under EU MDR.
  • Coordinate internal and external audits, including Notified Body audits related to CE marking.
  • Manage corrective and preventive actions (CAPA) in response to audit findings.
  • Monitor and ensure compliance with evolving European regulatory requirements.
  • Analyze HQMS data for reporting on quality system performance.

What we're looking for

  • At least 5 years of experience in medical device quality system compliance
  • Understanding of EU Medical Device Regulation (EU MDR) and CE marking processes
  • Knowledge of ISO 13485 standards and quality management systems
  • Ability to manage internal and external audits, including Notified Body audits
  • Strong project management skills with adaptability to dynamic environments
  • Excellent written and verbal communication for cross-functional team collaboration
  • Experience in technical documentation preparation and risk management

Employer

About Oracle

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