Director of Regulatory Affairs

Hep Quant is a clinical laboratory with headquarters in Denver and a CLIA-accredited lab in Aurora, Colorado. Hep Quant 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.

Hep Quant 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.

• 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.

• 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.

• Commitment to Hep Quant 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.

Hep Quant 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 online through Linked In and include a cover letter. No phone calls, please.

Note:

no third-party recruiters will be enlisted for this search.