Auditors / Product Reviewer / Clinical Specialist

Auditors / Product Reviewer / Clinical Specialist

Application

If interested, please send your Curriculum Vitae to

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