Senior EU MDR Compliance Lead for Medical Devices

Oracle; Concord (NH); Sur place; USD 74 000 - 148 000; Plein temps

Avantages offerts par ce poste

Health insurance

Disability coverage

Life insurance

401k with match

Paid time off

Paid holidays

Parental leave

Adoption assistance

Employee stock purchase plan

Financial planning

Résumé du poste

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance and EU MDR requirements. The role focuses on CE marking processes, conformity assessments, technical documentation, and post-market surveillance to enable EU market access.

The incumbent will support audits, CAPA, and monitor evolving European regulations, acting as a subject matter expert on EU market authorization while ensuring quality objectives across the

Qualifications

• 5+ years of relevant experience in quality/compliance.
• Understanding of quality management systems and risk management.
• Excellent written and verbal communication skills.
• Project management skills and ability to handle multiple priorities.
• Ability to adjust to changing priorities in a dynamic environment.

Responsabilités

• Provide quality system support through conformity assessment procedures and technical documentation.
• Develop and maintain medical device files, plus risk management and post-market surveillance for market access.
• Coordinate audits, including Notified Body audits related to CE marking.
• Support compliance with EU MDR and act as SME on EU market authorization.
• Monitor regulatory requirements and analyze HQMS data for management reporting.

Connaissances

5+ years experience

QMS & risk mgmt

Excellent communication

Project management

Adaptability

Formation

BA/BS or higher preferred

Description du poste

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance and EU MDR requirements. The role focuses on CE marking processes, conformity assessments, technical documentation, and post-market surveillance to enable EU market access.

The incumbent will support audits, CAPA, and monitor evolving European regulations, acting as a subject matter expert on EU market authorization while ensuring quality objectives across the