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Sr. Regulatory Specialist

Job

Advita Ortho

Gainesville, FL (In Person)

Full-Time

Posted 4 days ago (Updated 1 day ago) • Actively hiring

Expires 7/7/2026

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Job Description

Sr.
Regulatory Specialist Department:
Regulatory Employment Type:
Full Time Location:
Gainesville, FL Reporting To:
Sr. Manager Regulatory Affairs Description The purpose of the Senior Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company. Key Responsibilities With minimal oversight, preparing and maintaining pre-market submissions or post-market change submissions for a variety of markets. With minimal oversight, provide project-level regulatory strategy and support for new product development projects, postmarket lifecycle projects, Quality System updates, business development projects: Project team RA lead member Assess and approve post-market changes Assess and approve product and process Nonconformances and deviations Own and execute CAPA for Regulatory processes
Skills Knowledge and Expertise Education:
Bachelor's Degree from an accredited institution required
Experience:
Minimum 5 years experience in FDA/ISO medical devices quality management system standards required 5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required
Functional/Technical Knowledge, Skills and Abilities Required:
Technical writing skills required