Auditors, Technical & Clinical Experts — MTIC Group

Role overview

Job Application If interested, send your Curriculum Vitae to info@mtic-group.org ## Job Description MTIC InterCert of the MTIC Group is constantly and solidly growing in all areas of Certification, particularly as a Notified Body (CE 0068) for the Certification of Medical Devices.

For expansion of staff and for the opening of a new office in Emilia Romagna, we are looking for Technical Experts, Lead Auditors and Auditors for Conformity Assessment activities of Medical Devices pursuant to Regulation (EU) 2017/745.

The activities will include both the evaluation of technical documentation and audits of the Quality Management System (QMS), including audits according to EN ISO 13485.

This opportunity is exclusively reserved for candidates residing in Italy.

Work location: Rho/Emilia Romagna ##

• Requirements ### Product Reviewer / Final Reviewer
• Degree in engineering or chemical sciences or pharmacy
• Minimum 4 years of work experience with a medical device manufacturer, of which at least 2 years as a product reviewer with Notified Bodies
• Solid knowledge of Regulation (EU) 2017/745 and Directive 93/42/CEE (MDD)
• Solid knowledge of the main horizontal harmonized standards, including but not limited to ISO 14971, ISO 10993 series, EN 62366
• English language skills
• Preferable knowledge of MDR codes: MDA 0201, 0202, 0303, 0306, 0307, 0311, 0312, MDN 1102, 1201, 1202, 1203 ### Auditor
• Degree in engineering or chemical sciences or pharmacy
• Minimum 4 years of work experience with a medical device manufacturer
• Solid knowledge of Regulation (EU) 2017/745 and Directive 93/42/CEE (MDD)
• Solid knowledge of the main horizontal harmonized standards, including but not limited to ISO 13485, ISO 14971
• English language skills
• Lead Auditor training course according to ISO 19011 (40 hours) will be a preferential title ## Contact If interested, send your Curriculum Vitae to info@mtic-group.org