Sr. Regulatory Affairs Specialist (ADX-52-20)
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.
- Represent the regulatory department on project teams in the Personalized Cancer Monitoring programs by leading submission efforts, advising cross-functional partners and collaborating on successful product development.
- Manage regulatory resources within the Personalized Cancer Monitoring program.
- Assist the Personalized Cancer Monitoring clinical collaborations by providing compliance and trial design expertise.
- 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.
- 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.
- Direct experience supporting complex clinical trials from a regulatory standpoint.
- Experience writing FDA marketing applications (e.g. PMA, de novo 510(k)) for IVD products, acting as the primary submission author and/or RA core team representative.
- Eight (8) 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.