Regulatory Affairs Specialist (ADX-174-19)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- Assist with the development and implementation of regulatory procedures
- Operate as the primary contact for regulatory submissions, including, but not limited to, pre-submission meetings and marketing applications.
- Act as primary author and project representative for FDA IDE, 510(k), PMA submissions and EU Technical Files.
- Take on assignments from project core teams and support other initiatives on a departmental basis.
- Maintain marketing authorizations and approvals through change management and, if necessary, drafting and submission of supplements or change notifications to regulatory authorities.
- Review of the documentation associated with the support and continued manufacturing for Companion Diagnostics.
- Perform other duties as assigned by supervisor
- High degree of proficiency with MS Office and Adobe PDF creation.
- Demonstrable, hands-on experience with substantial medical, technical or regulatory writing. A writing sample is welcome.
- Experience writing FDA marketing applications (e.g. PMA, de novo 510(k)) for IVD or medical device products, acting as the primary submission author.
- Two (2) or more years of regulatory affairs experience in medical devices.
- Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
- Ability to work independently, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team environment
- Minimum B.S./B.A.