Director of Regulatory Affairs

HepQuant, LLC; Denver (CO); On-site; USD 90,000 - 110,000; Full time

Job summary

A clinical laboratory is seeking a Regulatory Affairs specialist in Denver, Colorado, with at least 8 years of experience. The role involves preparing documents for regulatory submissions, engaging with FDA and cross-functional teams, and reviewing promotional materials. Ideal candidates should have strong analytical and communication skills, and experience with FDA/EU submissions is essential. RAC Certification is preferred. Join to contribute to innovative blood-based tests that support clinical management.

Qualifications

• Minimum of 8 years’ experience in Regulatory Affairs & Quality.
• RAC Certification preferred.
• Experience preparing FDA and EU product submissions required.
• Strong working knowledge of all U.S. regulations that affect Class III combination drug/devices.

Responsibilities

• Plan and prepare document packages for submission to global regulatory agencies.
• Interact with FDA and/or other regulatory bodies for submissions.
• Engage with cross-functional stakeholders, including Medical Affairs and Quality.
• Responsible for regulatory review of promotional material and product documentation.

Skills

Regulatory Affairs

Quality Assurance

FDA submissions

Technical writing

Analytical thinking

Tools

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

Job description

HepQuant is a clinical laboratory with headquarters in Denver and a CLIA-accredited lab in Aurora, Colorado. HepQuant develops minimally invasive, blood-based quantitative tests that measure liver health. Our tests deliver information about liver cell function and portal-systemic shunting, attributes of liver disease that are associated with clinical outcomes. Results may be used by a physician in conjunction with clinical evaluation and other tests to aid clinical management.

About the Role

HepQuant is seeking a dedicated and motivated individual to be responsible for development, implementation, and execution of strategies for regulatory approvals to introduce new and modified products to market, advising on regulatory requirements, preparing regulatory submissions, and negotiation of their approval. This position reports to the CEO and President.

Responsibilities

• Plan and prepare document packages for submission to global regulatory agencies (IDEs, PMAs, annual reports, and CE marking design dossiers and technical files). Prepare IDE and PMA annual reports and Justifications to File.
• Interact with FDA and/or other regulatory bodies for submissions and projects.
• Engage with cross-functional stakeholders, including Medical Affairs, Quality, and Laboratory functions.
• Act as liaison with government officials in support of product approvals.
• Responsible for regulatory review of promotional material, labeling content, product and process changes, and product documentation.
• Exercise independent judgement in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents.

Qualifications

• Minimum of 8 years’ experience in Regulatory Affairs & Quality.
• RAC Certification preferred.
• Demonstrated experience getting FDA clearance or approvals.
• Experience with regulatory filings of combination products, CTD and /or software.
• Experience preparing FDA and EU product submissions required (MDR, IVD-R, EMA).
• Experience achieving CE Mark for devices.
• Strong working knowledge of all U.S. regulations that affect Class III combination drug/devices.
• Strong understanding of global regulations.
• Data interpretation, basic statistical analysis, and technical writing skills necessary for describing and summarizing laboratory and/or clinical data in submissions.
• Advanced experience with Microsoft Word, PowerPoint, Excel.

Required Skills

• Commitment to HepQuant Vision and Values.
• Hands-on work: ability to compile own reports, studies, data.
• Detail oriented, able to work individually, while also proving their ability to work collaboratively with colleagues, and teammates to create a results-driven, team-oriented environment.
• Demonstrates a strong professional work ethic, while striving to meet personal and organization performance goals.
• Excellent written, verbal, and interpersonal communication skills with an acute ability to listen attentively and to communicate effectively throughout all levels of the organization.
• Analytical thinker with demonstrated ability to perform root cause analysis, prepare and implement action plans, and lead improvement initiatives.
• Ability to function as a strong member of a highly motivated and integrated management team.

Equal Opportunity Statement

HepQuant is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status.

Apply

Apply online through LinkedIn and include a cover letter. No phone calls, please. Note: no third-party recruiters will be enlisted for this search.