The Director of Regulatory & Quality Affairs role represents an excellent opportunity to join an established liver diagnostic company about to apply for its first PMA. HepQuant, LLC is focused on becoming the standard for measuring liver health across the full spectrum of disease severity in a cost effective and minimally invasive way to patients across the globe. Our patented/pending technology has been used in 16 different clinical trials, on more than 770 patients. This is a unique position to advance a career in the Regulatory Affairs/Quality function. The successful candidate will lead the RA/QA function with a goal of commercializing new and innovative technology.
The candidate we seek will develop, implement and execute strategies for regulatory approvals to introduce new and modified products to market, advise on regulatory requirements, prepare regulatory submissions, and negotiate their approval. Candidate will also manage the Quality Management System and all Quality Assurance functions.
You will be responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings, and research regulatory issues and provide guidance and advice to colleagues. Lead the development of regulatory strategies for new claims and indications. Lead and manage the Quality Management Program, CAPA investigations, root cause determinations, situation analyses, risk evaluations and regulatory assessments, and manage consultants/support staff.
Duties and 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.
Represent regulatory affairs on product development and commercialization teams related to our products.
Interact with FDA and/or other regulatory bodies for submissions and projects.
Act as liaison with government officials in support of product approvals.
Monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance.
Responsible for regulatory review of promotional material, labeling content, product and process changes, and product documentation.
Develop a variety of solutions to regulatory challenges.
Exercise independent judgement in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents.
Responsible for planning, response of Internal, Regulatory and QMS audits or investigations
Responsible for all design and implementation of Quality Management System (QMS) Develop, write, maintain, administer, train, and manage quality systems standard operating procedures (SOPs) that can be used effectively and meet FDA and ISO quality system requirements
Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
Exercise judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Provide strategic regulatory guidance to management and interdisciplinary project teams.
Ensure schedules and performance requirements are met.
Requires a minimum of 8 years’ experience in Regulatory Affairs & Quality
A Bachelor’s degree is required; Master’s degree is preferred
RAC Certification preferred
Demonstrated experience getting FDA clearance or approvals
Experience preparing FDA and EU product submissions required
Experience implementing and managing FDA Quality Systems Regulation (eg., 21CFR 820, ISO 13485) required
Experience achieving CE Marks for drug/devices
Strong working knowledge of all U.S. regulations that affect Class III combination drug/devices
Strong understanding of global regulations
Willingness to be part of a fast-paced organization and possessing a hands-on, roll-up-your-sleeves mentality
Excellent time management and communication skills; strong problem-solving and analytical ability
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
Relocation to Denver-metro area required
Ability to travel 10%
Additional Salary Information: Commensurate with experience.
Internal Number: DIRQARA
About HepQuant, LLC
HepQuant is a privately-held, early-stage medical diagnostics company with unique, patented and patent-pending technology for assessing liver function of patients with chronic liver disease. HepQuant technologies, licensed from the University of Colorado Denver (UCD), have been advanced with the intent to profoundly impact the liver disease landscape – including the research, treatment and patient communities – with diagnostic products that are accurate and minimally invasive.
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