Regulatory Affairs II
SciStaff Services - Jacksonville, FL

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SciStaff Services, LLC is a business partner to global pharmaceutical and biotechnology firms. Our purpose is simple: we are changing the world by assisting pharmaceutical clients find talented professionals necessary to bring life saving therapies to patients worldwide. We are committed to making a difference in the lives of pharmaceutical professionals by assisting them in finding meaningful careers that will directly impact the quality of care.

One of our clients, a Fortune 500 Pharmaceutical Company, is currently seeking a Regulatory Affairs professional for their Jacksonville, FL, location.

Responsibilities:
  • Maintain the database for tracking change requests.
  • Review, analyze and evaluate post approval manufacturing changes for contact lens products, and determine the appropriate regulatory pathway.
  • Prepare internal documentation in support of 510(k) and PMA products.
  • Assist with the technical preparation of PMA Supplements and FDA Annual Reports.
  • May provide regulatory support for business critical projects.
Requirements:
  • Bachelors Degree - Scientific Discipline (preferred)
  • 1 - 2 years of working experience within the Pharmaceutical or Medical Device Regulatory environment.
  • Strong communication, organizational, negotiation and interpersonal skills.
  • Ability to organize and analyze data and identify issues or gaps.
  • Ability to provide innovative solutions within the boundaries of Regulation.
  • Proficient use of Microsoft Office Suite including Outlook.
Find out why Fortune 100 pharmaceutical & biotechnology clients consistently rank SciStaff Services, LLC as their business partner of choice when identifying permanent and contract talent in Clinical Development, Medical Affairs, Regulatory, QA and Drug Safety

NO relocation, NO sponsorship; US based candidates only, please.

Qualified candidates, please send current Word resume to: marci@scistaffonline.com for immediate consideration.

All work will be done on site. No virtual/remote work

Monster - 17 months ago - save job - block
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