Regulatory Affairs Manager (ADX-027-18)

Published:

Mar 1, 2018

Department:

Quality Assurance

Location:

Boulder, CO
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Position Summary

The Regulatory Affairs Manager, reporting to the Quality Director, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creating and maintain the documentation associated with filing for high risk medical device for the US and OUS submissions.

Responsibilities

  • Manage/assist with the development and implementation of regulatory procedures
  • Manage communication with regulatory agencies
  • Lead creation and manage filings for IDE, 510(k), PMA and Technical Files
  • Review of the documentation associated with the support and continued manufacturing for Companion Diagnostics
  • Perform other duties as assigned by supervisor

Growth

  • This hire may be transitioned to higher positions within Quality and/or Regulatory as experience and skills prove appropriate.

Experience

  • Minimum 5 years' experience with FDA and/or EU regulations
  • Experience with regulatory submissions including IDE, 510(k), and PMA for IVD and/or Companion Diagnostics
  • 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

  • B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred Experience with quality assurance or experience as a quality engineer

Company Description

ArcherDX, the NGS applications company, is developing and commercializing a novel approach to target enrichment chemistry. Next-generation sequencing technology based on Anchored Multiplexed PCR (AMP™) generates a highly enriched library of gene targets of interest for downstream genomic sequencing. Complemented by proprietary software and readily accessible reports, our technology enables dramatic enhancement in mutation detection speed as well as complex mutation identification and discovery.

Unless otherwise stated, all descriptions above are preferred but not required for our ideal candidate. Consideration will be given for comparable experience. ArcherDX is an Equal Opportunity Employer.

We offer competitive compensation and generous benefits programs. E-mail your résumé in confidence with salary requirements to careers@archerdx.com.


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Principals only. Recruiters, please do not contact this job poster

How to contact us

Address

2477 55th Street, Suite 202

Boulder, CO 80301

Phone

Phone: (877) 771 1093

Phone: (303) 357 9001

All content © 2018 ArcherDX, Inc.

For Research Use Only. Not for use in diagnostic procedures. For Research Use Only. Not for use in diagnostic procedures.