Summit Biolabs is harnessing the power of liquid-biopsy for the detection of COVID-19 and aerodigestive tract cancers. Spun out from CU Anschutz. In one year, Summit Biolabs has grown from a startup to a commercial-stage molecular diagnostics company. To help combat the COVID-19 pandemic, we leveraged its competencies in viral detection in saliva and direct to PCR platform technology to develop highly accurate, rapid, high-throughput swab and saliva PCR tests for COVID-19. The company’s CLIA laboratory is in Bioscience 3 on the Fitzsimons Innovation campus in Aurora, Colorado. If you are interested in helping us detect disease and transform diagnostic testing, then we’d like to hear from you!
In this new position on our team, you will be providing strategic regulatory guidance on existing and new product development. You will drive the adoption of standards and quality throughout the organization. Your success in securing FDA approval and CE Marking in the clinical diagnostic or device sector will be key to your success. You might even have experience with breakthrough device designation submissions – yep! That’s what we’re after! If your up for a fun, intense and world changing ride then we should chat.
Spend your days:
- Developing, implementing and maintaining regulatory procedures to ensure compliance
- Managing essential regulatory aspects of new product development and approval
- Assisting in the development and implementation of regulatory strategies for existing and new product introduction.
- Creatively approaching regulatory strategy, thinking what could be done, not necessarily what should be done
- Preparing domestic and international submissions that meet all standards and content requirements
- Working closely with consultants to push timely acceptance
- Continuously monitoring global, federal and state regulations for new guidance, updates, or policies
Show us your:
- BS/MS degree in a Life Sciences discipline and Regulatory Affairs Certification (RAC)
- At least 8 years of experience securing FDA approvals and CE marking in the clinical diagnostics or medical device sectors
- Proven experience in writing high-quality, evidence-based documents
- Knowledge of global rules, regulations, and guidance governing laboratory tests in all phases of development
- Experience preparing regulatory product submissions including pre-market and new product
- Extensive understanding of Quality Systems (FDA QSR / ISO 13485) and Regulatory Affairs Processes
- Proven ability to develop and implement regulatory strategies evaluating the potential impact on overall project/product strategy
- Nimble and strategic problem solving with the ability to manage multiple projects delivering complete, accurate information within deadlines
- Exceptional communication skills, written and verbal, with an innate ability to listen actively and query insightfully
- Excellent computer skills including MS Office and Google Suite
- A passion for contributing to a biotech startup – we’re running fast and blazing a trail here!
Our team members enjoy:
- Salary $150 - 180k plus benefits and equity
- The opportunity to be a part of a groundbreaking science
- A team of brilliant minds to spend your days with
Goldstone Partners is helping this brilliant team of researchers find a driven professional who wants to be part of something big! Please send your resume to us directly at firstname.lastname@example.org. Applicants welcomed from US Citizens and those holding a current US Greencard.