Regulatory Affairs Specialist jobs in Colorado

Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com.

 

The position will have broad and critical responsibilities that include supporting regulatory compliance to the Company's (all sites) Quality Management System (QMS) to comply with all governing regulatory bodies such as CLIA, New York State CLEP, College of American Pathologists (CAP), ISO 13485 and FDA QMSR, IVDR and others as they relate to the Company's products and services. This position will be responsible for maintaining Biodesix regulatory licensing, certification and permits for all sites.  Preparing and supporting document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company. This position compiles all materials required in submissions, license renewal and annual registrations. The ability to conduct regulatory assessments and gap analyses. Coordinating Regulatory improvement projects. Maintaining Regulatory Intelligence Library with current knowledge base of existing and emerging regulations, standards, and guidance documents.

 

RESPONSIBILITIES:

 

 

 

This role shall comply, at a minimum, with the responsibilities and qualifications outlined in:

 

 

 

 

 

We are excited to provide:

Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.