As a Product Assessor you’ll be responsible for conducting Sterilisation product assessments and technical file reviews in compliance with all applicable requirements including the European Medical Device Directive and Medical Device Regulation for Class IIa /IIb and/or Class III. You’ll ensure that reviews are technically sound and in compliance with all applicable requirements.
You’ll also support CE marking activities carried out by SGS, support in training and qualification of more junior staff, and create training materials.
You’ll communicate with team members and
client with regards to the product assessment or other activities performed and work to minimise risks associated with medical device certification.
The successful candidate will bring extensive experience within medical device manufacturing. You’ll have experience and knowledge in the operation of the relevant sterilization processes (ETO, Irradiation, Steam, Aseptic etc.), clean room controls, including validation of the considered process for which they wish to be qualified.
Experience of conducting sterilisation Product Assessments for another Certification/Notified body (Sterilisation-Technical File reviewer) would be advantageous.
In addition the ideal candidate will also bring;
- A degree or equivalent qualification which includes Microbiology modules or relevant studies e.g. medicine, pharmacy, engineering or other relevant sciences
- Good communication techniques through electronic mediums
- Good written English skills (as reports will be reviewed/queried in English)
- Medical device/ procedure packs Sterilisation process knowledge is required in following methods-
- (MDS1005/ MDS1011)
- ETO Sterilization
- Irradiation Sterilization
- Steam (and dry) Sterilization
- Aseptic Sterilization
- any additional knowledge will be advantageous i.e.
- Hydrogen Peroxide (gas plasma)
- Any other sterilization methods for Medical devices
- Non-active, non-implantable devices for disinfection, cleaning and rinsing (MDN1211)
- Solutions for disinfecting medical devices, contact lens care, catheter lock solutions
- Devices manufactured in clean rooms and associated controlled environments (MDT2008)