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 working experience as a quality engineer, preferably within 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. Please apply via Workable; or you may email a cover letter and resume to Jobs@LightDeckDx.com with applicant name and the job title listing in the subject line.
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.
Internal Number: 11/20
About LightDeck Diagnostics
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.