Senior EU MDR Medical Device Compliance Lead

Oracle; Helena (MT); Sur place; USD 74 000 - 148 000; Plein temps

Avantages offerts par ce poste

Medical/Dental/Vision

Disability insurance

Life Insurance

Company 401(k) match

Paid time off

Paid holidays

Sick leave

Parental leave

Adoption assistance

Employee stock purchase plan

Résumé du poste

Oracle Health seeks a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, emphasizing CE marking processes and EU MDR requirements. You will support conformity assessment, technical docs, risk management, and post-market surveillance to ensure market access.

The role requires coordinating internal and external audits, including Notified Body activities, managing CAPA, and monitoring regulatory changes as an EU SME.

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, 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.
• Assist with monitoring changing European regulatory requirements and act as SME on EU market authorization.
• Maintain up-to-date knowledge of regulations, collaborate with cross-functional teams to meet quality objectives, analyze HQMS data, and support supplier quality activities.

Connaissances

5+ years of experience

Quality management

Risk management

Communication skills

Project management

Adaptability

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, emphasizing CE marking processes and EU MDR requirements. You will support conformity assessment, technical docs, risk management, and post-market surveillance to ensure market access.

The role requires coordinating internal and external audits, including Notified Body activities, managing CAPA, and monitoring regulatory changes as an EU SME.