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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Scientific Officer Medical Devices


Reference:SCAXQP-013822 Location: Dublin
Qualification:DegreeExperience:1-2 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Scientific Officer, Medical Devices
Our client, a large regulatory body are currently recruiting for a Scientific Officer to join their Medical Devices department.

Responsibilities

  • Manage all medical device and in-vitro diagnostic device (IVD) vigilance issues, minimising risk to public health and ensuring compliance to relevant legislation
  • Coordinate and implement the organisations market surveillance activities for medical device and IVD technologies
  • Designation and ongoing oversight of the performance of notified bodies for medical devices and IVDs
  • Inspection of economic operators
  • Assess technical and regulatory aspects of medical device and IVD technologies
  • Communicate and engage with stakeholders on medical device and IVD issues
  • Manage Safety/Information notices, competent authority reports/notifications and other case specific communications
  • Develop technical guidance and capabilities at national and EU level
  • Engage with the European network on medical device and IVD issues, regulatory development and joint working initiatives
  • Contribute to work associated with implementation of relevant legislation, guidance, standards and relevant change and development initiatives
  • Ensure effective and efficient responses to all medical device and IVD vigilance and market surveillance issues that arise.
  • Ensure that the assessment of technical data for medical devices (including active implantable devices) and IVDs are carried out effectively and efficiently across the organisation’s medical device regulatory activities (e.g. review of clinical investigations applications, notified body designation and oversight).
  • Ensure that accurate regulatory information is provided to and understood by economic operators and that medical devices and IVDs assessed comply with relevant regulatory requirements
  • Ensure specific projects are carried out as required
  • Provide support and technical advice within the Medical Devices Department as required
Requirements
  • A relevant 3rd level degree such as engineering (biomedical, electrical/electronic, mechanical, software); OR science (e.g. biomedical, computer, health, materials, physics, pharmacy); healthcare professions (e.g. nursing, physiotherapy) or related disciplines
  • A relevant post graduate qualification (e.g. biomedical engineering, medical physics, health informatics, regulatory affairs, science or a related discipline)
  • Relevant post-graduate experience in the medical device or in-vitro-diagnostic device sector in manufacturing, quality, research & development or regulatory affairs
  • In depth understanding and technical knowledge of specific medical device and IVD technologies
  • Knowledge of the regulatory environment including knowledge of the current and forthcoming European and National legislation
  • Be a self-starter, capable of negotiation and decision making
  • Be highly motivated and with the ability to manage deadlines
  • Have excellent administrative and organisational skills
  • Demonstrate initiative and team working capabilities
  • Proven ability to work unsupervised
  • Proven organisational, communications, presentation, report writing and interpersonal skills

For more information please contact Sinéad Cullen on +353879500821 or [email protected]