Compliance Systems Supervisor (34537)
On-site · Jacksonville, Florida, United States
Job Summary
Lead regulatory software systems governance for RA/QMS, driving CSA validation, risk assessments, and documentation. Manage departmental operations including budget oversight, onboarding strategy, and digital workspace optimization (e.g., SharePoint, Wrike). Develop and maintain CSA governance procedures and templates, design and monitor compliance dashboards with Power BI, and ensure audit readiness. Partner with IT, Operations, and Manufacturing to align CSA activities with business needs; support automation opportunities, change control, and continuous process improvement while maintaining regulatory compliance across FDA, ISO standards, and global requirements.
Required Qualifications
- 4-year degree
- 4 years of relevant experience
- Previous leadership experience in a regulated company
- Documented training to ISO 13485
- Proficient with Microsoft Power Platform including Power BI
- Strong knowledge of FDA regulations and ISO standards
- CSA methodologies and software lifecycle understanding
- Proven track record in cross-functional project leadership and regulatory readiness
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