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