Regulatory Affairs Associate in Saint Paul, MN at Volt

Date Posted: 9/10/2018

Job Snapshot

  • Employee Type:
  • Job Type:
  • Duration:
    12 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Regulatory Affairs Associate (3-month contract)


St. Paul, MN

Volt has partnered with a growing client in search of a Regulatory Affairs Associate! In this exciting role, you will be responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.


  • Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III implantable medical devices.
  • Help write regulatory submissions: 510k and Health Canada. Send out regulatory assessments and compile results.
  • Work on filling international requests.


  • Requires an advanced degree and 5-8 years of direct experience in the field.
  • Recent experience with Class III implantable medical devices.
  • Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
  • Relies on extensive experience and judgment to plan and accomplish goals.

Volt is an Equal Opportunity Employer