EU MDR Compliance Lead – Medical Device Quality

Oracle; Augusta (ME); On-site; USD 74,000 - 148,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Short/Long-term disability

Life insurance

AD&D

401(k) match

Paid time off

Paid holidays

Sick leave

Stock Purchase Plan

Financial planning

Voluntary benefits

Job summary

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality systems and EU MDR conformity for CE marking, with a focus on regulatory support and documentation.

The role includes conformity assessment, CAPA, audits with Notified Bodies, risk management, and post-market surveillance. You will collaborate with QA, Regulatory, and Supply Chain to ensure regulatory compliance and timely market access.

Qualifications

• Minimum 5 years of relevant experience.
• BA/BS or advanced degree preferred.
• Knowledge of quality management system standards and risk management.
• Excellent written and verbal communication skills.
• Project Management skills.
• Ability to adjust 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 audits including Notified Body audits related to CE marking and assist with CAPA.
• Monitor regulatory requirements and act as subject matter expert on EU market authorization.

Skills

Quality management

Risk management

Communication

Project management

Adaptability

Regulatory knowledge

Education

BA/BS or higher

Job description

Oracle Health is seeking a Senior Compliance Specialist to guide cross-functional teams on medical device quality systems and EU MDR conformity for CE marking, with a focus on regulatory support and documentation.

The role includes conformity assessment, CAPA, audits with Notified Bodies, risk management, and post-market surveillance. You will collaborate with QA, Regulatory, and Supply Chain to ensure regulatory compliance and timely market access.