Senior Medical Device Auditor & Lead Auditor; EU MDR

Overview

MTIC Inter Cert of MTIC Group is steadily and solidly growing in all areas of Certification, particularly as a Notified Body (CE 0068) for Medical Device Certification. Due to staff expansion and the opening of a new office in Emilia-Romagna, we are looking for Technical Experts, Lead Auditors, and Auditors for Medical Device Conformity Assessment activities in accordance with Regulation (EU) 2017/745.

Activities will include both technical documentation assessments and Quality Management System (QMS) audits, including audits according to EN ISO 13485. This opportunity is exclusively available to candidates residing in Italy.

Work location:

Rho / Emilia-Romagna

Product Reviewer / Final Reviewer

• University degree in engineering, 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 for Notified Bodies
• Sound knowledge of Regulation (EU) 2017/745 and Directive 93/42/EEC (MDD)
• Sound knowledge of the main horizontal harmonized standards including, but not limited to, ISO 14971, ISO 10993 series, EN 62366
• Knowledge of the English language
• Knowledge of the following MDR codes is preferred: MDA 0201, 0202, 0303, 0306, 0307, 0311, 0312, MDN 1102, 1201, 1202, 1203

• University degree in engineering, chemical sciences, or pharmacy
• Minimum 4 years of work experience with a medical device manufacturer
• Sound knowledge of Regulation (EU) 2017/745 and Directive 93/42/EEC (MDD)
• Sound knowledge of the main horizontal harmonized standards including, but not limited to, ISO 13485, ISO 14971
• Knowledge of the English language
• Lead Auditor training course according to ISO 19011 (40 hours) will be considered an advantage