EU MDR & CE Mark Compliance Lead for Medical Devices

Oracle; Olympia (WA); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) Savings/Matching

Paid time off

Paid parental leave

Job summary

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking and EU MDR requirements. The role covers conformity assessment, technical documentation, risk management, CAPA, and post-market surveillance to enable market access for medical devices.

The ideal candidate has 5+ years of relevant experience, a BA/BS or higher, and strong communication skills.

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.

Responsibilities

• Provide quality system support through conformity assessment procedures and documentation.
• Assist with CE marking processes and EU MDR regulatory requirements.
• Coordinate and assist with internal and external audits, including Notified Body audits.
• Support CAPA and post-market surveillance activities.
• Monitor regulatory changes and act as a subject matter expert on EU market authorization.
• Collaborate with cross-functional teams to meet quality objectives and report HQMS data.

Skills

Quality management

Risk management

Project management

Communication skills

Adaptability

Education

BA/BS or advanced degree preferred

Job description

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on CE marking and EU MDR requirements. The role covers conformity assessment, technical documentation, risk management, CAPA, and post-market surveillance to enable market access for medical devices.

The ideal candidate has 5+ years of relevant experience, a BA/BS or higher, and strong communication skills.