Sr. Regulatory Specialist

Advita Ortho • Gainesville, FL

1d • Onsite

About The Position

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.

Requirements

• Bachelor’s Degree from an accredited institution required
• 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
• Technical writing skills required

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior