Overview
MTIC InterCert is growing steadily in all areas of Certification, particularly as a Notified Body in Medical Device Certification. Technical Experts, Lead Auditors, Auditors and Clinical Specialists for Conformity Assessment activities for Medical Devices according to Directive 93/42/EEC and soon, for EU Regulation 2017/745, are welcome to cooperate with our team at our offices in Europe. Activities will include both technical documentation assessments and QMS audits, including EN ISO 13485 audits.
Auditor
* University degree in engineering discipline or chemical science or pharmacy
* Minimum 4 years of work experience in medical manufacturer, of which at least 2 years in quality management or as auditor for other notified bodies
* Sound knowledge of MDD 93/42/EEC and Regulation (EU) 2017/745
* Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 13485, ISO 14971
* Knowledge of English language
* Lead Auditor training course according to ISO 19011 (40 hours) will be a plus
Product Reviewer/Final Reviewer
General Requirements:
* University degree in engineering discipline or chemical science or pharmacy
* Sound knowledge of Regulation (EU) 2017/745
* Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 14971, ISO 10993 series, EN 62366
* Knowledge of English language
Specific Requirements
MDA 0303 Active Non-implantable Devices Utilising Hyperthermia / Hypothermia
* 4 years in the medical device sector or similar sector
* of which at least 2 years in design with manufacturers of medical devices for hyper/hypothermia, or
* at least 2 years in NB with experience in PR for hyper/hypothermic devices
MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
* 4 years in the medical devices sector or similar, of which possibly
* at least 2 years in NB with experience in FR for active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis, or
* at least 2 years of experience in design of active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis with FR training to be carried out in NB
MDA 0311 Active non-implantable dental devices
* 4 years in the medical devices sector or similar, of which possibly
* at least 2 years in NB with experience in FR for active dental devices, or
* at least 2 years of experience in design of dental active devices with FR training to be carried out in NB
MDA 0316 Medical gas supply systems and parts thereof
* 4 years in the field of medical devices or similar, of which possibly
* at least 2 years of experience in design of medical gas delivery systems, or
* at least 2 years in NB with experience in PR for medical gas delivery systems
MDN 1102 Non-active osteo- and orthopaedic implants
* 4 years in the field of medical devices or similar, of which possibly
* at least 2 years in NB with FR experience for orthopaedic implants, or
* at least 2 years of experience in design of orthopaedic implants with FR training, carried out by NB
MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
* 4 years in the field of medical devices or similar, of which possibly
* at least 2 years in NB with FR experience for non-implantable devices for anaesthesia, emergency and intensive care, or
* at least 2 years of experience in design of non-implantable devices for anaesthesia, emergency and intensive care with FR training, carried out by NB
MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
* 4 years in the field of medical devices or similar, of which possibly
* at least 2 years in NB with FR experience for Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis, or
* at least 2 years of experience in design of Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis with FR training, carried out by NB
MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
* 4 years in the field of medical devices or similar, of which possibly
* at least 2 years in NB with FR experience for catheters, or
* at least 2 years of experience in design of catheters with FR training carried out by NB
MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
* 4 years in the medical device sector or similar sector
* of which at least 2 years in design at manufacturers of non-active medical devices for disinfection and cleaning, or
* at least 2 years in NB with PR experience for non-active disinfection and cleaning devices
Clinical Specialist
MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
* at least 2 years of clinical practice in the use of diagnostic imaging devices with ionising radiation (e.g. CT, X-ray, etc.)
MDA 0315 Software
* at least 2 years of clinical practice in the use of stand-alone medical software
MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
* at least 2 years of clinical practice in the use of devices for extra-corporal circulation, administration or removal of substances and haemapheresis
MDA 0307 Active non-implantable respirator devices
* at least 2 years of clinical practice in the use of non-implantable respirator devices
MDA 0310 Active non-implantable devices for ear, nose and throat
* at least 2 years of clinical practice in the use of devices for ear, nose and throat
MDA 0316 Medical gas supply systems and part thereof
* at least 2 years of clinical practice in the use of devices for supply of medical gas
MDN 1201 Non active non-implantable devices for anaesthesia, emergency and intensive care
* at least 2 years of clinical practice in the use of devices for anaesthesia, emergency and intensive care
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