Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Company Description
BioPathogenix specializes in molecular diagnostics for infectious disease testing. We offer a range of products, including multiplex qPCR reagents, attenuated pathogen quality control, and alternate proficiency testing. Our focus is on providing accurate and reliable testing solutions to healthcare professionals.
Role Description
This is a full-time on-site role for a Regulatory Affairs Specialist in the Lexington–Fayette metropolitan area, KY. BioPathogenix seeks a Regulatory Affairs Specialist with Medical device submission experience with the FDA and EU. The Regulatory Affairs Specialist will manage regulatory documentation, ensure regulatory compliance, understand and implement regulatory requirements, and prepare regulatory submissions.
The ideal candidate will:
Qualifications
Job Type: Full-time
Pay: From $75,000.00 per year
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Work Location: Hybrid remote in Nicholasville, KY 40356
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0 Regulatory Relations Specialist jobs found in Lexington, KY area