Regulatory Affairs Specialist
Kelly Services - Jacksonville, FL

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Job Description:
Regulatory Affairs Specialist
Every day, Kelly Scientific Resources (KSR) connects
clinical research professionals with opportunities to
advance their careers. We currently have an exciting
contract opportunity for a Regulatory Affairs Specialist
working with our client based in Jacksonville, FL.

Job Responsibilities (other duties may be assigned):
  • Maintains database for tracking change requests.
  • Reviews, analyzes and evaluates post approval
manufacturing changes for client 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.
  • General knowledge, understanding and application of
principles, concepts and practices of FDA
regulations.
  • 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.
  • No travel required with the exception of local
transportation needed to work between campuses.
  • Maintains the change request database.
  • Reviews change requests and documents the regulatory
assessment.
  • Prepares and submits PMA supplements and annual
reports to FDA.
  • Assists project teams with identification of data
requirements and coordinates the collection of data
and documents to meet post approval submission.
  • Performs other related duties as assigned by
management.
For immediate consideration, click the Apply Now button,
or refer a friend by clicking the E-mail this job link
provided.
Kelly Scientific Resources® has grown into a $270
million global business as the scientific business unit
of Kelly Services. Our recruiting consultants place
clinical, regulatory and medical affairs, data
management and biostatistics professionals to the
pharmaceutical, biotechnology, medical device, CRO and
university research communities.
We invite you to bookmark our Web site and encourage you

to review it regularly for new opportunities worldwide:
www.kellyscientific.com.
Kelly Services is an Equal Opportunity Employer.
Job Code : BHJOB3479_596919

Kelly Services - 19 months ago - save job - block
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About this company
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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...