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about 1 month ago
Support Services Group (SSG)
Salary: excellent benefits
Location: Weston-super-Mare
Job type: Permanent
Contact: Collective Recruit
Category: Admin Jobs, Bilingual Jobs, Customer Service Jobs, Office Junior Jobs

Medical Devices Technical Coordinator - (x2 Roles Permanent and Maternity Contract)
Weston Super Mare, Somerset
Highly competitive salary plus attractive Bonus, private medical, pension & 23 days holidays

Do you have a biomedical or medical devices background? Are you looking to develop your career in a global medical devices technical team?
My client is a dynamic global company providing certification, audit and accreditation services and have an exciting opportunity for a Technical Coordinator to join them. This role will involve supporting on the production of audit proposals, planning of audits and assisting with technical queries within medical devices global teams.
This role will suit someone with a biomedical background and strong administrative skills who has either graduated with a sciences /medical degree or has equivalent experience within pharma, clinical, nursing, biology, electronics relevant to medical devices.


Key responsibilities:

  • To review client vigilance reports, monitor trends in client reporting,
  • To ensure affiliates are made aware of vigilance issues for their clients, and that audits are planned accordingly to address vigilance concerns
  • To operate as a technical resource within the medical team and ensure that technical queries are adequately answered or forwarded to the appropriate technical expert or manager
  • To operate as lead GMDO resource for remedial technical actions for affiliates
  • To undertake the day to day management and co-ordination of the technical documentation review process for EC Design Examinations and selected technical files. This includes liaison with clients, contractors and external agencies to ensure efficient technical file and design dossier reviews, and ensuring clients are informed at all times
  • To review and approve the Technical file Matrices to ensure technical file sampling is undertaken to regulatory requirements
  • To perform an initial review of audit packs to ensure that administrative and regulatory errors are removed prior to technical pack review and ensure maximum utilisation of the technical pack approver allocated time
  • To review medical device questionnaires and prepare proposals
  • To co-ordinate the technical documentation review process undertaken by contractors to ensure timely delivery of outputs
  • To assist in the planning of audits, ensuring appropriate allocation of audit resources to ensure auditor time is fully utilised.
  • Answer queries from affiliates and clients in a timely manner, ensuring a prompt and efficient service
  • To undertake partial reviews of medical device technical documentation to ensure the maximum chargeability
  • Assist in other administrative tasks related to medical devices certifications


Skills & Knowledge

  • Significant technical experience via device clinical use or design/manufacture
  • Able to understand new technical issues relating to medical devices quickly
  • Experience of databases and spreadsheets
  • Experience of quality or quality systems
  • Experience with an area of medical devices or medical procedures
  • Ability to understand technical issues relating to medical devices
  • A tertiary technical qualification relevant to medical devices to meet GHTF educational requirements - e.g. electronics, nursing, biology, pharmacy, materials.
  • Quality training - Internal audit training, knowledge of the medical devices directive and ISO13485 is desirable but not essential


If this sounds like you and you are looking for a fresh challenge, then please apply now or call Stephanie Taggart at Collective Recruit Ltd to discuss this in more detail .

Our client has appointed Collective Recruit as their resource partner & we are managing this role on their behalf. To apply for this position please click on the "apply now" button below. Your details as submitted by you, will only be forwarded in relation to this vacancy; by submitting your CV to us you are giving us express consent to provide our client with your full details if we believe your skills and experience meets with our client's criteria and/or need.


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