Regulatory Affairs Associate

2 weeks ago

Santa Clara, United States The Fountain Group Full time
The Fountain Group is a national staffing firm and we are currently seeking a Regulatory Affairs Associate for a prominent client of ours. This position is located in Santa Clara, CA Details for the position are as follows:

Job Description:
Details:
  • Pay for this position is 40.00 to 45.00 hourly depending on experience.
  • This position is a contract with the possibility of extension or conversion to permanent.

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.
  • 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.

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