EU MDR Compliance Lead – Medical Devices & CE Mark

Oracle; Lansing (MI); Sur place; USD 74 000 - 148 000; Plein temps

Avantages offerts par ce poste

Health insurance

Disability coverage

401(k) plan

Paid vacation

Paid parental leave

Résumé du poste

Oracle Health seeks a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking under EU MDR. You will coordinate conformity assessment activities and maintain technical documentation for market access.

The role requires strong knowledge of risk management, CAPA, and post-market surveillance, plus excellent communication and project management skills.

Qualifications

• 5+ years of relevant experience in quality/compliance for medical devices.
• BA/BS or advanced degree preferred.
• Knowledge of quality management systems and risk management.
• Strong written and verbal communication skills.
• Project management skills and ability to adapt to change.

Responsabilités

• Provide quality system support through conformity assessment procedures, technical documentation, and medical device file development.
• Coordinate internal and external audits, including Notified Body audits related to CE marking.
• Assist with monitoring regulatory changes and manage supplier quality activities.

Connaissances

Quality management systems

Project management

Excellent communication

Regulatory compliance

Risk management

Formation

BA/BS or advanced degree preferred

Description du poste

Oracle Health seeks a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking under EU MDR. You will coordinate conformity assessment activities and maintain technical documentation for market access.

The role requires strong knowledge of risk management, CAPA, and post-market surveillance, plus excellent communication and project management skills.