Senior EU MDR Compliance Lead - Medical Device Quality

Oracle; Salem (OR); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Paid time off

Paid holidays

Paid sick leave

401(k) with company match

Employee stock purchase plan

Job summary

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality system compliance, focusing on EU MDR CE marking processes. You will support conformity assessments, document creation, risk management, and CAPA activities.

The role requires 5+ years of relevant experience, strong communication, and the ability to adapt to changing priorities in a fast-paced environment within the US market. Competitive benefits included.

Qualifications

• 5+ years of relevant experience.
• BA/BS or advanced degree preferred.
• Understand 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.

Responsibilities

• Provide quality system support for conformity assessment procedures, CE marking, and EU MDR compliance.
• Prepare technical documentation and medical device files.
• Perform risk management and post-market surveillance activities.
• Coordinate internal and external audits, including Notified Body audits.
• Assist with monitoring regulatory requirements and advise on EU market authorization.

Skills

Quality management

Communication skills

Project management

Adaptability

Regulatory compliance experience

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 EU MDR CE marking processes. You will support conformity assessments, document creation, risk management, and CAPA activities.

The role requires 5+ years of relevant experience, strong communication, and the ability to adapt to changing priorities in a fast-paced environment within the US market. Competitive benefits included.