Oracle
The Regulatory Affairs Specialist manages international and domestic regulatory registrations and submissions for medical devices, ensuring compliance with FDA and international regulations. This role involves drafting 510(k) notifications, maintaining technical documentation, and coordinating with regional teams to secure product clearances. The position requires interpreting regulatory requirements, training staff, and supporting quality system procedures to meet business objectives.
Oracle Corporation is a multinational technology company that builds enterprise software, cloud infrastructure, and engineered systems for large organizations. Best known for the Oracle Database, the company also offers a broad portfolio of enterprise applications (ERP, HCM, CX), analytics, middleware, Java, and hardware, plus Oracle Cloud Infrastructure (OCI) with SaaS, PaaS, and IaaS services. Oracle supports customers through consulting, managed services, and global technical support to migrate and modernize mission‑critical systems. Enterprises choose Oracle for its integrated stack, scalable performance, and enterprise‑grade security and reliability.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for Oracle.
30% above the average for this role
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