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Regulatory Affairs Associate

Company: System One
Location: Raritan
Posted on: April 10, 2021

Job Description:

Title: Regulatory Affairs Associate Location: Raritan, NJ or Rochester, NY Start date: ASAP Responsibilities:

  • Support base business activities, such as responding to International Regulatory requests via the IRRT tool.
  • Drafting and managing Change notifications to International Regulatory colleagues in support of developing regulatory registration impact assessments associated with product changes/updates.
  • Support regulatory colleagues to prepare their submissions by performing tasks such as completing Regulatory forms, letters of Explanation, and submssions for Apostille and Legalization as well as editorial reviews of submission content.
  • With oversight, provide regulatory support to Clin Labs and Transfusion Medicine project teams in terms of submission requirements, timing, and risks.
  • Interact with US and/or International regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters.
  • Prepare submissions to meet regulatory agency expectations.
  • Identify and/or support process improvement projects to streamline current activities and increase department efficiencies.
  • Maintain tracking systems to reflect updated information associated with work content.
  • Maintain evidence of adequate training for the role.
  • Perform other work-related duties, as assigned. Requirements:
    • A minimum of a Bachelor's Degree in a scientific or related discipline is required.
    • Minimum 3-5 years of experience in a regulated Medical Device or Pharmaceuticals Industry required, IVD Industry experience preferred.
    • A minimum of 2 years of experience developing and executing Regulatory strategies in support of Market Products and Product Development for Medical Devices is preferred, In Vitro Diagnostic experience is preferred.
    • Excellent interpersonal, teamwork and verbal/written communication skills are required.
    • Good organizational skills and an ability to manage multiple tasks/projects/priorities.
    • The ability to demonstrate model behavior, understand priorities and encourage others to drive for results will be needed.
    • Ability to cross-train with peers.
    • The ability to work with business partners across geographies and time zones is critical. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: System One, Trenton , Regulatory Affairs Associate, Other , Raritan, New Jersey

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