Location: Weston-Super-Mare, United Kingdom
Salary: £24,000 - £29,000 per annum
Type: Permanent, full-time
My client who is based in Weston-super-Mare have an opportunity for a Technical Coordinator to join them on a permanent basis.
They are the global leader in their field so this is an excellent opportunity.
The successful candidate will be primarily responsible for supporting the medical devices team in the production of audit proposals, planning of audits and answering of technical queries to ensure KPI’s on turnaround of documentation and financial targets both globally and in the UK are met.
To manage and co-ordinate responses to Compliance and Enforcement notifications (“COEN”) related to vigilance issued by member states.
To support affiliates in their medical devices activities to ensure future growth of medical device certification worldwide.
To review client vigilance reports, monitor trends in client reporting, and to ensure appropriate action is taken in a timely fashion.
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 resource for remedial technical actions for affiliates.
To undertake the day to day management and co-ordination of the technical documentation review process, 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
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 remains within the business
Significant technical experience, either via device clinical use or design / manufacture.
Significant office or administrative experience.
Experience of databases and spread sheets.
Able to demonstrate attention to detail.
Team working ability.
Able to organise own work load and day to day priorities.
Able to understand new technical issues relating to medical devices quickly.
Able to work under pressure.
A tertiary technical qualification relevant to medical devices to meet GHTF educational requirements – e.g. electronics, nursing, biology, pharmacy, materials.
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.
Ability to read/speak a foreign language
Quality training – Internal audit training, knowledge of the medical devices directive and ISO13485.
If you would like to be considered for this role then please send your cv to me today.
Salary: £24,000 - £29,000 per annum depending on experience.
Benefits: 10% performance bonus, retail discount scheme, private health cover after 1 years’ service, contributory stakeholder pension scheme and life cover. Hours are 37.5 a week Monday to Friday.
Change Recruitment Services Limited provides services as an Agency and an Employment Business, and is committed to equal opportunities for all candidates.