Senior Regulatory Compliance Specialist Medical Device

at Oracle in Boise, Idaho, United States

Job Description

Oracle Health is a comprehensive suite of healthcare technology solutions designed to help organizations advance patient care, improve operational efficiency, and enhance caregiver experiences. Building on Oracles global expertise in cloud technology, data management, and analytics, Oracle Health delivers integrated electronic health records ( EHR ), population health tools, and data-driven insights for hospitals, clinics, and health systems. By connecting data and workflows across the continuum of care, Oracle Health empowers providers to make informed decisions, streamline processes, and drive better health outcomes.

The Senior Compliance Specialist provides guidance to cross-functional teams on medical device quality system compliance, with a focus on quality system support for CE marking processes and requirements under the EU Medical Device Regulation (EU MDR ).

Responsibilities

The Senior Compliance Specialist will 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. The Senior Compliance Manager coordinates and assist with both internal and external audits, including Notified Body audits related to CE marking, and helps manage corrective and preventive actions ( CAPA ). They assist with monitor compliance with changing European regulatory requirements and act as a subject matter expert on EU market authorization.

The incumbent maintains up-to-date knowledge relevant regulations, works collaboratively with cross-functional teams to meet quality objectives, analyses HQMS data and metrics for management reporting, and supports supplier quality management activities.

Key Skills and Requirements

+ 5 plus years of relevant experience

+ BA/BS or advanced degree preferred

+ Have an 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 in a dynamic environment.

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Disclaimer:

Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.

Range and benefit information provided in this posting are specific to the stated locations only

US: