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Maxime TIROUVANZIAM

Quality & Regulatory, SIEMENS HEALTHCARE

Paris - France

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French biomedical engineer with experience in regulatory affairs, quality assurance and quality control management. Result-oriented approach combined with good communication skills, flexibility, team spirit and a high level of commitment.

Schools attended

génie biomédical (MST & DESS GENIE BIOMEDICAL)
Université Toulouse 3 Paul Sabatier (IUP - Ingénierie Santé)

Since 2008: SIEMENS HEALTHCARE

Quality & Regulatory
Sector: Medical equipment

2004 - 2008 : SNITEM

Regulatory & Technical affairs Associate Director, Head of business statistics
work for the SNITEM, the french trade association for biomedical companies.

- European and French regulations (Diective 93/42/EEC, 2007/47/EC ...).
- Standardization (ISO, IEC ...).
- Proactive work with french and european competent authority, notified body and others associations.
- Management of work groups
- Economic surveys on different sectors and activities of medical devices in France.
- Quality system Auditor (ISO 9000).
Sector: Medical equipment

2003 : Afssaps

Biomedical engineer - Intern
Evaluation of medical devices issues reported through the french vigilance system, in particular issues related to imaging appliances, electrochirurgy equipment,beds,...
Sector: Medical equipment

2002 : Pierre Fabre, Inc. / Physicians Formula, Inc.

Quality assurance associate
- Qualification and validation of production process and in particular the cleaning in order to give evidences the quality system was in compliance with requirements of the 21 CFR.

- Writing of SOP for stability monitoring of active substances.
Sector: Cosmetic - Perfume - Hygene products

2000 - 2001 : DEPUY Bioland - a Johson&Johnson company

R&D Associate
- Enhancement of physical properties of Hydroxyapatite (HAP) in order that it remains white even after plasma coating and sterilization by gamma Ray.
Sector: Medical equipment

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