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Regulatory Affairs Associate

Company: Nesco Resource
Location: Raritan
Posted on: April 9, 2021

Job Description:

Summary: The primary responsibility is to support the day-to-day Regulatory Affairs base business operations within both Clinical Laboratories and Transfusion Medicine . The RA Associate, with oversight, will also manage and oversee the coordination, compilation and submission of documentation in support of regulatory applications to health authorities. This position will have significant regular interactions with Regulatory staff located globally. This position is in either Pencoed, Wales, UK; Raritan, NJ; or Rochester NY. 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. Qualifications:
    • 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. Key Working Relationships: Must maintain excellent working relationships with Domestic and International Regulatory Affairs colleagues, R&D, Operations, Global Publications, Regional QRA partners and Business Managers located in the Regions, i.e. ASPAC, EMEA, China, LAR and quality / compliance partners.

      Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.

Keywords: Nesco Resource, Trenton , Regulatory Affairs Associate, Other , Raritan, New Jersey

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