MTIC InterCert is growing steadily and successfully 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/EC and soon, for EU Regulation 2017/745 are always 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.
We are currently looking for the following additional specific requirements:
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 10993series, 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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