Carl Guillemot

Regulatory affairs for the medical gases of the company (medicinal products and medical devices), e.g. maintenance activities, variations, etc. Involvement in Pharmcovigilance and Materiovigilance activities (SOPs, responsibilities, etc.). Participation to GMP audits and inspections. Participation to audits according to DIN EN ISO 13485. PRRC according to Art. 15 MDR. Informationsbeauftragter gem. § 74a AMG (German Medicinal Product Information Officer).

General Regulatory Affairs (MAA, variations, maintenance), in EU, USA + further individual countries, for medical devices & cosmetics. Risk Management (ISO 14971). Medical devices manufactured with tissues of animal origin (Commission Regulation 722/2012). Successful TSE-CEP application @ EDQM. Preparation of a Site Master File (SMF) for application purposes.

General Drug Regulatory Affairs in Germany and other EU countries. Regulatory intelligence/strategy. Writing of CTD modules 2.3 and 3, and IMPD/IB. Preparation, compilation as eCTD, submission of MAAs/variations/reply to deficiency letters under consideration of the valid procedural rules. Project management.

Project assissant.