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Mechelen

    vp ra/qa/ca - Mechelen, België - Nipro Europe Group

    Nipro Europe Group
    Nipro Europe Group Mechelen, België

    3 dagen geleden

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    Beschrijving

    About the job

    Reporting to the CEO, the Regulatory Affairs, Clinical Affairs and Quality Assurance VP (RAQACA) is responsible for leading the RA/QA/CA team within the Nipro Medical Europe (NME) organization, to assure compliance to all applicable quality and regulatory requirements for Medical Devices.

    The role holder will ensure that NME and its Manufacturing facilities meet the obligations described in the Medical Devices Regulations for their respective Roles (Authorized Representative, Importer and distributors for NME and Legal Manufacturers, including regulatory compliance, Vigilance, Post Market Surveillance and Clinical Evaluation). Additionally, the holder is responsible for product registrations according to the applicable country/market requirements within the NME territory.

    There will be 4 teams to manage for a total of 20 people in the RAQA department

    What You'll do

  • Ensure regulatory affairs processes are conducted to current country regulations and requirements (MDD, MDR, BREXIT, ....)
  • Ensure processes are developed to ensure compliance with environmental requirements (REACH, CLP, WEEE, ...) for the distribution and import of medical devices.
  • Integrate regulatory and clinical planning, in collaboration with other functional leaders, in planning for new or modified products or processes
  • Coordinate with other functional leaders to review and agree registration timelines and resource requirements.
  • Ensure that the Regulatory and environmental non-compliance is communicated to NME Management Team
  • Act as the PRRC (Person Responsible for Regulatory Compliance) to verify regulatory compliance of the Medical Devices where NME is Authorized Representative as described in MDR 2017/745.
  • Manage, guide and coach the RA Team to create and/or maintain compliance to the applicable regulatory requirements.
  • Accountable for incident reporting to the Competent Authorities (Back Up of Complaint and PMS Manager)
  • Ensures team meet regulatory requirements related to timely reporting, accurate and comprehensive medical device reporting and follow-up, timely and comprehensive response to Competent Authority inquiries, and another global governmental agency request, in closed collaboration with the product Legal Manufacturers.
  • Ensure that any Complaint and PMS non-compliance is communicated to NME Management Team
  • Manage, guide and coach the Complaint and PMS Team
  • Ensure creation of a clinical Strategy, Planning, and management of Nipro Medical Europe Clinical Studies in collaboration with NME Marketing Team and Global Product Development Team
  • Ensure that the Clinical Evaluation process are in accordance with the applicable regulation and with the internal procedures (applicable only for NME Legal Manufacturers)
  • Act as the Management Representative for NME in accordance with ISO 13485:2016
  • Ensure the processes needed for the Quality Management System are established, implemented and maintained.
  • Ensure that the performance of the Quality Management System is communicated to Management Team including any areas of improvement.
  • Ensure that NME internal audits occur according to the plan and to the applicable regulation and internal procedure. Where necessary, conduct audits on supplier's premises. Manage, Guide and coach the QMS Team

    • What You'll need

  • A university degree in scientific field or equivalent by experience
  • Strong experience in RA and QA departments within Medical Devices sector
  • Experience with MDR's
  • Very good people manager, able to lead Managers
  • Ability to create and lead a strategy
  • International experience

    • Why You should apply

  • You will be part of the EMEA Nipro Medical Management Team
  • EMEA position within a HQ
  • 30 different nationalities
  • Growing company
  • Diversified role
  • Set up strategies for your departments
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