Oracle · 21 hours ago
Senior Regulatory Compliance Specialist
United States
Full-time
Remote
Mid, Senior Level
$71K/yr - $141K/yr
5+ years expOracle Health is a comprehensive suite of healthcare technology solutions designed to help organizations advance patient care and improve operational efficiency. The Senior Compliance Manager provides guidance on medical device quality system compliance and manages various responsibilities related to regulatory requirements and quality objectives.
Data GovernanceData ManagementEnterprise SoftwareInformation TechnologySaaSSoftware
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 and assist with both internal and external audits, including Notified Body audits related to CE marking, and help manage corrective and preventive actions (CAPA)
Assist with monitoring compliance with changing European regulatory requirements and act as a subject matter expert on EU market authorization
Maintain up-to-date knowledge of relevant regulations, work collaboratively with cross-functional teams to meet quality objectives, analyze HQMS data and metrics for management reporting, and support supplier quality management activities
Qualification
Required
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
Benefits
Medical, dental, and vision insurance, including expert medical opinion
Short term disability and long term disability
Life insurance and AD&D
Supplemental life insurance (Employee/Spouse/Child)
Health care and dependent care Flexible Spending Accounts
Pre-tax commuter and parking benefits
401(k) Savings and Investment Plan with company match
Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
11 paid holidays
Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
Paid parental leave
Adoption assistance
Employee Stock Purchase Plan
Financial planning and group legal
Voluntary benefits including auto, homeowner and pet insurance
Company
Oracle
Oracle is an integrated cloud application and platform services that sells a range of enterprise information technology solutions.
10001+ employees
H1B Sponsorship
Oracle has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1271)
2024 (846)
2023 (995)
2022 (1192)
2021 (985)
2020 (755)
Funding
Current Stage
Public CompanyTotal Funding
$25.75BKey Investors
Sequoia Capital
2025-09-24Post Ipo Debt· $18B
2025-02-03Post Ipo Debt· $7.75B
1986-03-12IPO
Leadership Team
Esteban Rubens
Healthcare Field CTO
G
Gerard Warrens
Field CTO, Business Strategy and Transformative Technologies
Recent News
2026-01-10
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Business Insider
2026-01-09
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