Sr. Regulatory Specialist

Department: Regulatory

Location: Gainesville, FL

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