Regulatory Affairs Associate in Maplewood, MN at Volt

Date Posted: 1/10/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Maplewood, MN
  • Job Type:
  • Duration:
    12 weeks
  • Date Posted:
    1/10/2020
  • Job ID:
    213172
  • Pay Rate
    $37.71/Hour
  • Contact Name
    Volt Branch
  • Phone
    913-201-4928

Job Description

Regulatory Affairs Associate

Plymouth-up to $90.00 an hour depending on experience!

12-24 mths.

Volt is seeking and experienced Reg. Affairs Associate for an industry leader of medical devices.

Description:

  • 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.

Preferred Skills:

  • 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.
  • May lead and direct the work of others.
  • A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

Local candidates only as this is a higher level position.

Volt is an Equal Opportunity