Auditors / Product Reviewer / Clinical Specialist

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