Regulatory Affairs Specialist

at  Biodesix Inc

ABOUT US:

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. Learn more about us at biodesix.com.

COMPETENCY OR POSITION REQUIREMENTS:

• Excellent analytical and problem-solving skills.
• Impeccable communication, presentation and interpersonal skills.
• Strong data mining and metric presenting skills.
• Able to travel out-of-state.
• Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects, communicating when necessary with company personnel to execute.
• A motivated self-starter able to perform the required responsibilities with minimal direction.
• Ability to work as part of internal and remote teams with a strong understanding and appreciation of other department/personnel’s work disciplines.
• Strong research and regulatory interpretation skills.
• Ability to apply requirements fit for purpose of the regulatory environment.
• Competency in Microsoft Office (SharePoint, Teams, Word, Excel, PowerPoint)

EDUCATION AND EXPERIENCE:

• A Bachelor’s/Master’s degree in a scientific discipline or related field and at least 5 years Quality or Regulatory experience in a regulated healthcare environment. Regulatory experience preferred.
• At least 3 years specific experience in one or more of the following areas:
• Clinical laboratory experience preferred, as it relates to commercializing a regulated product with an ability to understand the complexities involved with in vitro diagnostic multivariate index assays.
• Experience with FDA IVD applications and approvals.
• Experience in a regulated environment and strong knowledge of FDA QMSR, ISO 13485, CLIA/CAP and NYS CLEP regulations and standards.
• Strong proficiencies with computer skills, Microsoft Office, Microsoft Excel, Microsoft Outlook, PowerPoint, etc.

REGULATORY REQUIREMENTS:

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

• CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493
• CAP: College of American Pathologists (CAP): All Common, General, Director Responsibility and Authority and all test-specific checklists
• NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5
• ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016
• All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD

PHYSICAL REQUIREMENTS:

• The physical demands described here are representative of those that must be met by a team member to successfully perform the essential functions of this job
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• While performing the duties of this job, the team member is regularly required to use hands to grip, handle, or feel objects, tools, or controls and talk or hear
• The team member frequently is required to sit, walk, and reach with hands and arms; occasionally is required to stand, stoop, kneel, crouch, or crawl, and must occasionally lift and/or move more than 25 pounds
• Specific vision abilities required by this job include visual acuity to Colorado driver’s license requirements

RESPONSIBILITIES:

• Accountable for the organization, research, communication, maintenance, and growth of the Biodesix Regulatory Intelligence Library and addressing all regulatory inquiries in a timely manner.
• Maintains list of all applicable Standards and Regulations which apply to all Biodesix facilities and products.
• Maintains Biodesix regulatory licensing, certification and permits for all facilities including renewals, new assay notifications, site or lab director changes, etc. including updating and maintaining current regulatory status on websites (CAP.org, NYS HCS) and internal tracking spreadsheets (submissions, licenses/permits, etc.)
• Manages and maintains industry standards and guidance subscriptions (CLSI, RAPS, etc.), maintains relationships with industry organizations and communicate any output to stakeholders.
• Assists with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
• Reviews, approves, or escalates copy review and marketing material for compliance with Claims Matrix and applicable regulations.
• Reviews proposed product changes for impact on regulatory status of the product.
• Interprets and applies FDA and other industry regulations and standards to business practices and fit for purpose.
• Assists with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.
• Reviews and approves proposed labeling and regulated records and documents for compliance with applicable US and international regulations.
• Write, edit, and upkeep of departmental standard operating procedures with management and team.
• Follows Biodesix regulatory affairs policy and procedures.
• Assist with internal and external audits.
• May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
• Other responsibilities as assigned.

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

• CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493
• CAP: College of American Pathologists (CAP): All Common, General, Director Responsibility and Authority and all test-specific checklists
• NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5
• ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016
• All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, M