MTIC InterCert 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
We are currently looking for the following additional specific requirements:
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
Auditor 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
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