Regulatory Affairs Associate (ADX 173-19)
ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion and grit to meet these goals.
Make it happen by joining us in the fight against cancer.
- Assist with the development and implementation of regulatory procedures
- Assist in the communication with regulatory agencies
- Support creation and manage filings for IDE, 510(k), PMA and EU Technical Files.
- Take on assignments from project core teams and support other initiatives on a departmental basis.
- 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
- Preference for candidates with 3-12 months' experience with FDA and/or EU regulations
- Working familiarity with regulatory submissions including IDE, 510(k), and PMA for IVD and/or Companion Diagnostics
- 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.