What are the responsibilities and job description for the Regulatory Affairs Specialist position 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. For more information about Biodesix, please visit www.biodesix.com.
OBJECTIVE OF THE POSITION:
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:
- 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.
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
WORK ENVIRONMENT:
- The work environment characteristics described here are representative of those a team member encounters while performing the essential functions of this job
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- The primary work environment is an office setting
- The noise level in the work environment is usually moderate
UNPLANNED ACTIVITIES:
- Other duties as assigned
TRAVEL PERCENTAGE:
- Minimal
COMPENSATION:
We are excited to provide:
- Competitive compensation $64,800 - $76,200 annualized
- Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
- Discretionary Bonus opportunity
- Comprehensive benefits package – effective date of hire
- Medical
- Dental
- Vision
- Short/Long Term Disability
- Life Insurance
- Flex Spending Account
- 401(k)
- 120 hours of annual vacation
- 72 hours of paid sick time off
- 11 paid holidays
- 3 floating holidays
- Employee Assistance Program
- Voluntary Benefits
- Employee recognition program
JOB LOCATION:
- Louisville, CO
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.
Salary : $64,800 - $76,200
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