Job Details

  • Title: Regulatory Affairs Associate Jr
  • Code: RCI-5401
  • Location: Santa Clara California (CA) 95054
  • Posted Date: 09/25/2020
  • Duration: 12 Months
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  Job Description

  • Responsible for filing necessary applications and handling global regulatory submissions pertaining to the regulation process for products requiring governmental approval.
  • Authoring and submitting 510k or PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Experienced with CE and International product registration/submission.
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III medical devices.
  • May require an advanced degree and 5-8 years of direct experience in the field.
  • Recent experience with Class II and/or Class III medical devices;
  • Proven successful track record of authoring/submission/approval of Class III PMA supplements or 510k clearance; knowledge of US FDA guidance documents and EU MDR regulation.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.
  • A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
This is the outline for the Junior Level.

Description:

0-2 years experience in a medical device regulated industry Skills: Ability to schedule and organize multiple projects

Education: BS Engineering or Science/Medical

Duties:
  • Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams.
  • Manage regulatory submissions and ensure timely regulatory approval of medical devices.
  • Ensure all client product and procedures comply with applicable regulatory agency requirements and guidelines.