Regulatory Affairs Associate (ADX 173-19)
COMPANY OVERVIEW:
p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px 'Helvetica Neue'}p.p2 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px 'Helvetica Neue'; min-height: 14.0px}
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.
POSITION SUMMARY:
The Regulatory Affairs Associate, reporting to the Regulatory Affairs Director, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintenance of the documentation associated with filing for high risk medical device for the US and OUS submissions.
RESPONSIBILITIES:
- 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
QUALIFICATIONS
- 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
EDUCATION:
- Minimum B.S./B.A.