Senior EU MDR Compliance Lead — Medical Devices

Oracle; Hartford (CT); Sur place; USD 74 000 - 148 000; Plein temps

Résumé du poste

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.

You will support conformity assessment procedures, maintain technical documentation, manage CAPA, and coordinate Notified Body audits. You will monitor regulatory changes and act as a subject matter expert on EU market authorization.

The role requires 5+ years of relevant experience and a BA/BS is preferred.

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 and technical documentation preparation.
• Develop and maintain medical device files and perform risk management and post-market surveillance.
• Coordinate internal and external audits, including Notified Body audits related to CE marking.
• Monitor regulatory changes and act as SME on EU market authorization.

Connaissances

Quality management

Regulatory compliance

Project management

Written communication

Adaptability

Formation

BA/BS or advanced degree

Description du poste

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.

You will support conformity assessment procedures, maintain technical documentation, manage CAPA, and coordinate Notified Body audits. You will monitor regulatory changes and act as a subject matter expert on EU market authorization.

The role requires 5+ years of relevant experience and a BA/BS is preferred.