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Regulatory Affairs Associate in Minneapolis, MN at Volt

Date Posted: 6/8/2019

Job Snapshot

  • Employee Type:
    Contingent
  • Job Type:
  • Duration:
    20 weeks
  • Date Posted:
    6/8/2019
  • Job ID:
    182147
  • Contact Name
    Volt Branch

Job Description

Regulatory Affair Associate (5-month contract)

$80-90/hr.

Plymouth, MN

Responsibilities:

  • 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.

Qualifications:

  • May require 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