E U R O M E D A U T H O R I Z E D S E R V I C E S K F T

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EUROMED Authorized Services Kft is a leading certification body dedicated exclusively to healthcare and medical devices. Our team of seasoned experts brings deep industry knowledge and technical expertise in medical devices and conformity assessment. We are committed to delivering reliable, transparent, and high-quality certification services, helping our clients meet regulatory standards and ensure the safety and effectiveness of their healthcare products.

EUDAMED Project Manager.


Roles and responsibilities
Management of key Program activities relating to Program Planning, Status Reporting, Risk and Interdependency Management. Facilitate Program Decisions on key choice points relating to scope, schedule, resources and finances. Lead and collaborate with appropriate team members to ensure program status reporting and supporting visualisations are prepared to the appropriate standard and fit for purpose. Support preparation of Program Governance collateral ensuring content is prepared, refined and aligned to the correct standard. Leads cross-functional meetings to achieve consensus . Provides direction to project resources, monitors efforts, assembles key project deliverables and identifies issues and risks requiring escalation when reporting project status. Follows Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), and all regulatory requirements. Support Data Management related Business Process Design activities to facilitate the identification of appropriate people, process and technology solutions that support key business areas. Plan, schedule and track project timelines using appropriate tools.

Notified Body Product Assessor -Active Devices.


Role/Responsibilities:

  • Support CE marking activities carried out by notified body including support of sales, CWS approvers or scheduling team with technical queries
  • Ensure that reviews are technically sound and in compliance with all applicable requirements
  • Support in training and qualification of colleague and create training materials
  • Ensure adherence to policies, procedures, and processes
  • Communication with team members and client with regards to the product assessment or other activities performed
  • Minimise risks associated with medical device certification Key Accountabilities
  • Ensure regulatory compliance of product technical documentation assessment under applicable EU Medical Devices Directives and /or Regulations
  • Conduct product assessments (primarily desk-based, but occasionally may be on-site) in accordance with established procedures, maintaining a high standard of service delivery
  • Maintain personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis.
  • Project manage assessments as appropriate, to maximise efficiencies, enhance client satisfaction, and ensure compliance with requirements
  • To assist with queries raised from product assessments • Work at all times to adhere to KPIs set as an individual and within a team
  • Ensure that the highest level of service is provided throughout the network offering medical devices certification and stakeholders through efficient service delivery
  • Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and act in accordance with policies.

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