Senior EU MDR Compliance Lead - Medical Devices

Oracle; Dover (DE); Sur place; USD 74 000 - 148 000; Plein temps

Avantages offerts par ce poste

Medical/dental/vision insurance

Short-term disability

Long-term disability

Life insurance

AD&D

Supplemental life

FSAs

Commuter benefits

401(k) match

Vacation time

Paid holidays

Sick leave

Parental leave

Adoption assistance

ESPP

Financial planning

Voluntary benefits

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 manage conformity assessment, technical documentation, and risk management for market access.

Ideal candidates have 5+ years of relevant experience, strong communication, and project management skills, and can adapt to changing regulatory requirements across EU markets.

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 CAPA.
• 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 and collaborate with cross-functional teams to meet quality objectives.
• Analyze HQMS data and metrics for management reporting and support supplier quality management activities.

Connaissances

Experience 5+ yrs

Communication

Project management

Adaptability

Regulatory knowledge

Formation

BA/BS or advanced degree

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 manage conformity assessment, technical documentation, and risk management for market access.

Ideal candidates have 5+ years of relevant experience, strong communication, and project management skills, and can adapt to changing regulatory requirements across EU markets.