Regulatory Affairs Associate in Saint Paul, MN at Volt

Date Posted: 9/10/2018

Job Snapshot

  • Employee Type:
    Contingent
  • Job Type:
  • Duration:
    12 weeks
  • Date Posted:
    9/10/2018
  • Job ID:
    136908
  • Contact Name
    Volt Branch
  • Phone
    714-921-7483

Job Description

Regulatory Affairs Associate (3-month contract)

$35-36.50/hr.

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.

Responsibilities:

  • 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.

Qualifications:

  • 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