Senior Medical Device Compliance Lead – EU CE & Audits

Oracle; Little Rock (AR); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Paid time off

401(k) Savings and Investment Plan

Paid sick leave

Parental leave

Stock Purchase Plan

Flexible spending accounts

Job summary

Oracle Health in the United States seeks a Senior Compliance Specialist to support conformity assessment, risk management, and post-market surveillance for medical device market access. You will coordinate internal and external audits, including Notified Body audits for CE marking, and help manage CAPA while monitoring EU regulatory changes.

You will maintain up-to-date regulatory knowledge, collaborate with cross-functional teams to meet quality objectives, and analyze HQMS data for management

Qualifications

• 5+ years of relevant experience in quality/compliance.
• BA/BS or advanced degree preferred.
• Understanding of quality management system standards and risk management.
• Excellent written and verbal communication skills.
• Strong project management skills.
• Ability to adjust and adapt to changing priorities in a dynamic environment.

Responsibilities

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

Skills

Quality management systems

Risk management

Project management

Regulatory knowledge

Communication skills

Education

BA/BS or higher

Job description

Oracle Health in the United States seeks a Senior Compliance Specialist to support conformity assessment, risk management, and post-market surveillance for medical device market access. You will coordinate internal and external audits, including Notified Body audits for CE marking, and help manage CAPA while monitoring EU regulatory changes.

You will maintain up-to-date regulatory knowledge, collaborate with cross-functional teams to meet quality objectives, and analyze HQMS data for management