Senior EU MDR Regulatory Lead - Medical Device Compliance

Oracle; Trenton (NJ); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Short term disability

Long term disability

Life insurance and AD&D

Employee Stock Purchase Plan

401(k) Savings with company match

Paid time off and holidays

Paid parental leave

Adoption assistance

Job summary

Oracle Health in the United States is seeking a Senior Compliance Specialist who will guide cross-functional teams on medical device quality system compliance, with a focus on EU MDR CE marking processes.

You will manage conformity assessment activities, prepare technical documentation, and support post-market surveillance to facilitate EU market access while collaborating with internal teams and suppliers to meet quality objectives.

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 to changing priorities in a dynamic environment.

Responsibilities

• Provide quality system support through conformity assessment procedures, technical documentation, medical device file development and maintenance.
• Manage risk management and post-market surveillance for market access.
• Coordinate and assist with internal and external audits, including Notified Body audits related to CE marking.
• Assist with monitoring changes in European regulatory requirements and act as SME on EU market authorization.
• Collaborate with cross-functional teams to meet quality objectives and analyze HQMS data for management reporting.
• Support supplier quality management activities.

Skills

5+ years experience

Communication skills

Project Management

Quality management

Adaptability

Education

BA/BS or advanced degree preferred

Job description

Oracle Health in the United States is seeking a Senior Compliance Specialist who will guide cross-functional teams on medical device quality system compliance, with a focus on EU MDR CE marking processes.

You will manage conformity assessment activities, prepare technical documentation, and support post-market surveillance to facilitate EU market access while collaborating with internal teams and suppliers to meet quality objectives.