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My client, a leading medical device consultancy is now looking to expand. Because of this there is a need for somebody who has specific Sterilisation Expertise. This progressive consultancy is based in the east midlands and offers a great opportunity for someone with the correct experience.Main responsibilities for Medical Device Sterile Products Specialist:
* Provide consultation on Sterile products.
* Gamma Irradiation validation and routine requirements.
* Electron beam Irradiation validation and routine requirements.
* Ethylene Oxidegas validation and routine requirements.
* Cleanroom Operations and Environmental Monitoring.
* Product Packaging.
* Implications of Design Change.
* Provide consultation on Quality Management Systems.
* ISO 13485, 21 CFR 820, ISO 13485 CMDCAS and other Quality System standards as applicable to our customers.
* Write documentation including Technical Files, Design Dossiers, manuals, forms, templates, procedures etc as required for regulatory compliance of Customer's products.
* Write documentation including manuals, forms, templates, procedures etc as required to implement Management Systems.
* Provide consultation on medical devices guidance documents (MEDDEVs, NBMEDs, TS, TIR)
* Attend sales meeting with customers if required.
* Support the Sales Team in pre-sales and marketing activities.
* Attend training courses if required.
The successful Medical Device Sterile Products Specialist will have the following qualifications, skills and experiences: The ideal candidate will be degree qualified in Life Sciences, Microbiology or equivalent.
* Practical working knowledge of irradiation sterilisation methods.
* Knowledge of EtO sterilization.
* Knowledge of validation methods for sterilisation.
* Environmental monitoring of clean rooms.
* Thorough and practical working knowledge of ISO 13485.
* Practical working knowledge of Medical Devices Directive93/42/EEC and 2007/47/EC.
* Full UK driving licence and a car owner. If you feel you have the correct experience and would like to persue this role further, or if you have any questions, please feel free to call on 02077587322, or email on
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