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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