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EUMDR Regulatory Affairs Specialist

Company: LanceSoft Inc
Location: Raynham
Posted on: November 17, 2021

Job Description:

Job Description

Job Description...

  • Execute projects in accordance with the cadence.
  • Support communication strategy to NPD staff to maximize understanding of expected impact from the MDR program to NPI.
  • Collaborate with stakeholders to develop and maintain project plans.
  • Create, monitor and analyze project risks and identify mitigation strategies.
  • Be responsible for all project communications to all cross-functional project stakeholders and communications include: project websites, meeting minutes, status reports, presentations, and any other detailed project information needed.
  • Report metrics of completion status to manager / Leadership Team.
  • Work with project team to identify and address critical path or road block issues.
  • Ensure project plans and deliverables are compliant with appropriate design control procedures and any other applicable procedures and/or regulations.
  • Be the liaison with stakeholder managers as needed to ensure project goals are achieved.
  • Know and follow all laws and policies that apply to the job and maintain the highest levels of professionalism, ethics and compliance at all times.
  • To ensure timely execution of project objectives, the candidate must have strong problem-solving skills and initiative, and the ability to provide efficient escalation of issues to the appropriate accountable part.
  • Review and approval of documentation to support Technical Document to meet MDR requirements.
  • Participate in cross functional teams to discuss and revise documents to meet MDR requirements.
  • Support submission review process with Notified Body. *//
    Diversity, Equality, and Inclusivity This means a deep commitment to each other equally, in an open, diversified team environment. We strive to be as diverse as the clients and employees we partner with. We embrace people of any race, ethnicity, national origin, religion, gender identity, and sexual orientation. LanceSoft is a certified Minority Business Enterprise (MBE).
    //*

Keywords: LanceSoft Inc, Brockton , EUMDR Regulatory Affairs Specialist, Other , Raynham, Massachusetts

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