Regulatory Manager

Company: LightDeck Diagnostics
Location: Boulder
Posted on: January 6, 2021

Job Description:

Regulatory Manager LightDeck Diagnostics believes in a new approach to healthcare where fast, accurate, simple, low-cost diagnostic tests will be run wherever and whenever they are needed, without compromise. Our proprietary LightDeck-- platform combines an advanced laser waveguide with novel materials and patented manufacturing techniques to deliver lab-quality results anywhere, in minutes. We are introducing a portfolio of in vitro diagnostic panels; the first is an on-the-spot test for COVID-19. The LightDeck platform is currently commercialized in veterinary diagnostics and for environmental testing. Job Duties: Responsible for the activities related to regulatory compliance of all products at LightDeck Diagnostics, with a heavy emphasis on IVD products Contribute to and execute upon regulatory strategy for the organization Ensure regulatory compliance of devices and activities at LightDeck Work closely with Quality, Clinical, and R&D teams to ensure alignment Participate in audits and inspections Draft, revise with the team, and support regulatory submissions including 510(k)s, pre-submissions, Emergency Use Authorizations, CE Mark Technical Files, Device License Applications, and other submissions based upon business needs Guide and support V&V plan development, including clinical studies Review and advise on design changes to ensure proper change control and regulatory submissions are made, as appropriate Support investigations and own reporting requirements related to product issues and customer complaints Develop and support implementation of post market surveillance activities Candidate should have a background in FDA in vitro diagnostics regulations, specifically POC and CLIA-waived devices. Experience in veterinary (USDA) and/or environmental (EPA) regulations is also valuable. No single candidate is expected to have demonstrated skill in all functions listed below, but candidates should highlight relative experience in a brief cover letter. --- Proven on the IVD or medical device industry --- Working knowledge of ISO 13485:2016 standard --- Working knowledge of FDA and EU IVD regulations --- Experience related to the above listed Job Duty categories --- Proficient and experienced in spreadsheets, MS Office, statistical software, and other QMS software applications --- Outstanding technical writing and communication skills Education and Experience: --- Bachelor---s or higher degree in life sciences field. --- A minimum of 5 years IVD medical device industry experience with a minimum of 3 years in regulatory affairs. Applicant must have authorization to work in the U.S. Resumes must be accompanied by a cover letter explaining how the applicant meets the job requirements and desired skills. No phone calls, please. Note: no third-party recruiters will be enlisted for this search. LightDeck Diagnostics is an Equal Opportunity Employer committed to a culturally diverse workforce.

Keywords: LightDeck Diagnostics, Boulder , Regulatory Manager, Executive , Boulder, Colorado