Regulatory Affairs Specialist (ADX-380-20)
Regulatory Affairs Specialist (ADX-380-20)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
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.
- Evaluate customer complaints to determine if regulatory notification is required.
- Review of the documentation associated with the support and continued manufacturing for Companion Diagnostics.
- Perform other duties as assigned by supervisor
EXPERIENCE:
- High degree of proficiency with MS Office and Adobe PDF creation
- Preference for candidates with 3 or more months' experience with FDA and/or EU regulations
- 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.