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Regulatory Affairs Coordiantor

Company: Kelly Services
Location: Bridgewater
Posted on: April 9, 2021

Job Description:

Kelly Services is actively recruiting for a Regulatory Affairs Coordinator to work an ongoing contract assignment in Bridgewater, NJ.----Although some of the tasks can be done remotely, the position requires going into the office 1-2 times per week.----Please send your resume to Alicia Cali at alic091@kellyservices.com or call at 216.256.7768The Regulatory Affairs Coordinator will provide information and regulatory support to international RA team members for Product Registrations, Renewals, Launches, etc.Responsibilities of the Regulatory Affairs Coordinator includes:----

  • Provide support and needed information to all global regions on all US products product portfolio so that regions can file products with the needed documentation and information for their submissions.
  • Provide Regulatory Affairs support to International RA teams for product registrations, renewals to global markets for all US approved/cleared medical device products.
  • Provide support for all requested documents certificates/letters,--search and retrieve product labeling all needed support documentation.
  • With the oversight of Regulatory leadership will prepare and obtain: Letter of Authorizations/Letter of Declaration/Power of Attorney Letters Certificate of Free Sale from State of NJ/ CPP from Federal Agency FDA Notarized, Legalized, or Apostilled Regulatory Documents.
  • Work on Technical Inquiries and coordination including Manufacturing, process, raw materials, technical files - Search and retrieve documents from RA system and tools and provide links to the international requestors SharePoint, Clinops, Liquent /Insight viewer where information can be found.
  • Work with other International Support groups Operations, QA, etc. to provide assistance to regions.Requirements of the Regulatory Affairs Coordinator assignment includes:
    • Minimum of a B.S. in Biological Sciences or related sciences
    • Medical Device Regulatory Affairs experience required; 5 years of experience in Regulatory Affairs preferred with at least one year of global/international experience.
    • Strong computer skills (databases)----
    • Good communication and willingness to work globalWhy Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Trenton , Regulatory Affairs Coordiantor, Other , Bridgewater, New Jersey

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