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Regulatory Affairs Professional 2

  • Location

    Norwood, United States

  • Sector:

    Business Professional

  • Job type:

    Contract

  • Contact:

    Sonu Chouhan

  • Job ref:

    22922

  • Published:

    2 months ago

  • Expiry date:

    2021-01-26

Regulatory Technical Specialist II - IVDR Key Responsibilities:

  • Supports Regulatory Affairs in Project Team for implementing new EU In Vitro Diagnostic Medical Device Regulations (IVDR) within the Point of Care Business Line for Siemens Healthineers.
  • Responsible for executing a gap analysis of commercialized IVD products, reviewing reports, and providing guidance to Project Team for updating technical documentation, labeling, etc. for meeting the IVDR requirements.
  • Responsible for preparing summary technical documentation (STED) according to EU IVDR for Notified Body review.
  • Interacts closely with Regulatory IVDR project team lead and other functions, including Program Management, R&D, Clinical Affairs, Labeling, Risk Management, etc.
  • May support responses to Notified Body during the preparation and review of submissions.
  • May support additional regulatory registrations and functions outside the scope of IVDR

Preferred Skills:

  • 2 - 5 years experience in Regulatory Affairs, preferably with a global manufacturer of medical devices.
  • Experience with preparing 510(k)s, PreSubmissions, EU Essential Requirements Checklists/Technical Files and other regulatory submissions.
  • Strong attention to detail with organizational and technical writing skills.
  • Strong knowledge of US FDA, EU IVD and/or MD regulations
  • Experience working on multidisciplinary teams in a fast-paced, dynamic environment.
  • Strong written and verbal communication skills.
  • Well versed QSR Design Control requirements and in educating project teams on these

requirements.

  • Project Management Experience

Education:

  • BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.