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Regulatory Affairs Associate

Company: Real Staffing
Location: Santa Clara
Posted on: May 10, 2022

Job Description:

Job Description:
Regulatory Affairs Associate - Medical Device
Location: Santa Clara, CA
Contract: 12 Months + Potential extension or Full time opportunity
Compensation: (rate depends on experience)
Benefits: Real Staffing offers medical, dental, vision, 401K
**W2 Employment Opportunities - Unable to offer sponsorship**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.
  • Relies on extensive experience and judgement 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.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Keywords: Real Staffing, Santa Clara , Regulatory Affairs Associate, Other , Santa Clara, California

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