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Regulatory Affairs Associate job at Experis, Alameda

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Job Title: Regulatory Affairs Associate
Work Location: 2901 Harbor Bay Parkway Alameda California USA 94502
Contract Duration: 12+ months

Job Responsibilities:

  • 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.
  • 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.
  • Performs a variety of tasks. 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.

Job country: United States

City: Alameda

Category: Regulatory Affairs Specialists

Location: Alameda, CA, United States

Job posted 2022-06-04

This job is expired

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