Auditor/Project Manager - Active medical devices

The individual will be responsible for the effective and thorough management of assigned projects, including:

• Evaluating the documentation of Technical Files for accuracy and completeness.
• Conducting inspections at client facilities in accordance with ISO 9001, ISO 13485, and Directive 93/42/EEC.
• Guiding companies through their certification processes.
• Assisting, as appropriate, in the preparation of proposals and offers.
• Creating detailed reports on inspection activities.
• Contributing to the development of the internal Quality System as relevant.

• Background from another institution or as a Technical Director (CTF) in pharmaceutical companies that also operate in the medical device sector.
• Degree in Chemistry, Pharmacy, Biology, or a related field.
• 3-5 years of experience in the pharmaceutical industry, followed by experience in the medical device sector, or 3-5 years of experience specifically in the medical device sector involving substances.
• Knowledge of industry standards and regulations, including IEC 60601.
• Technical expertise in medical devices containing substances.
• Entrepreneurial mindset and strong organizational skills.
• Strong analytical abilities.
• Excellent interpersonal skills.
• Proficiency in English.
• Native Italian speaker or fluent in Italian.