EU MDR Compliance Lead - Medical Devices

Oracle; Frankfort (KY); Sur place; USD 74 000 - 148 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401(k) Savings with company match

Paid time off

Paid parental leave

Employee Stock Purchase Plan

Résumé du poste

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, with emphasis on CE marking under EU MDR and conformity assessment procedures. Responsibilities include technical documentation, risk management, CAPA, audits by Notified Bodies, and monitoring regulatory changes to ensure market access for medical devices.

Collaborate with teams and analyze HQMS data for management reporting, plus support supplier quality

Qualifications

• 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.

Responsabilités

• 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.
• Coordinate and assist with internal and external audits, including Notified Body audits related to CE marking, and help manage corrective and preventive actions (CAPA).
• Assist with monitor compliance with changing European regulatory requirements and act as a subject matter expert on EU market authorization.
• Maintain up-to-date knowledge relevant regulations, work collaboratively with cross-functional teams to meet quality objectives, analyse HQMS data and metrics for management reporting, and support supplier quality management activities.

Description du poste

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, with emphasis on CE marking under EU MDR and conformity assessment procedures. Responsibilities include technical documentation, risk management, CAPA, audits by Notified Bodies, and monitoring regulatory changes to ensure market access for medical devices.

Collaborate with teams and analyze HQMS data for management reporting, plus support supplier quality