Senior Regulatory Compliance Specialist
Listed on 2026-01-13
-
Healthcare
Health Informatics, Healthcare Management
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 Oracle’s 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 Manager 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).
ResponsibilitiesThe Senior Compliance Manager 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 assists 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 monitoring 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+ 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 in a dynamic environment.
QualificationsDisclaimer:
Certain US customer or client‑facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.
Range and benefit information provided in this posting are specific to the stated locations only.
US:
Hiring range in USD from $70,600 to $141,200 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle’s differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
Flexible vacation is provided to all eligible employees assigned to a salaried (non‑overtime eligible) position.
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level – IC3
Required Skills- CE Marking Process
- EU Regulatory Frameworks
- ISO 13485 Standards
- Quality Management System
- Regulatory Submissions
- Support of Internal and External Audits
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