Sr. Regulatory Specialist

Department: RegulatoryLocation: Gainesville, FLDescriptionThe 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 ResponsibilitiesWith 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 memberAssess and approve post-market changesAssess and approve product and process Nonconformances and deviationsOwn and execute CAPA for Regulatory processesSkills Knowledge and ExpertiseEducation:Bachelor’s Degree from an accredited institution requiredExperience:Minimum 5 years experience in FDA/ISO medical devices quality management system standards required5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations requiredFunctional/Technical Knowledge, Skills and Abilities Required:Technical writing skills required