Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (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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