Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall 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 Top Regulatory Affairs Executive 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, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (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