Marco Brolis

Responsibilities/Tasks -Responsible for worldwide certifications/renewals/amendments (50+ countries) of medical devices used for the treatment of cardiovascular diseases by angioplasty clinical procedures. -Leading a Team of five (5) RA Specialists, with strong experience in Regulatory projects management for product approvals in EU (CE marking), US, Japan, China, Canada, Eastern Europe, Latin America, MEA and APAC areas. -Responsible to sign EC Declaration of Conformity and assess the Regulatory impact for design/process/labeling changes. -RA direct contact for EU Notified Body and involved in audits by international Competent Authorities. -Knowledge of the new EU MDR and involved in the gap analysis vs, MDD 93/42/EEC, with evaluation of the remediation activities. -Reporting to Medtronic Vascular in US (Plymouth site). -Responsible of writing Regulatory procedures and providing related trainings.

Responsibilities/Tasks -Responsible for worldwide certifications/renewals/amendments (50+ countries) of 30+ medical devices used for the treatment of cardiovascular diseases by angioplasty clinical procedures. -Preparation, supervision and submission of class II/III Design Dossiers /Technical Files for CE marking and 510(k) for US FDA clearance. -Preparation of Summary Technical Documents (STED) for Asian, Middle East/Africa, Eastern Europe and Latin America countries. -Responsible for complaint handling, in direct contact with worldwide distributors/customers. -Responsible for EU vigilance system (incident notifications) to EU Notified Body and Competent Authorities. -In charge to write biological evaluation per EN ISO 10993 standards. -In charge to write clinical evaluations based on literature review. -Leading a three (3) RA Specialist Team.

-Employed in the technical office of a pharmaceuticals, cosmetics and food raw material distributor. I was in charge to write Regulatory declarations to customers, providing technical support.

-Employed in the research and development labs of ACS Dobfar S.p.A., responsible for the preparation of a lyophilized nano-formulation containing an antitumoral compound.

- Employed in the research and development labs. of Indena S.p.A. as Project Leader in charge of: -- synthesis and spectroscopic characterisation (by 1H, 13C-NMR, MS, UV, IR, HPLC-MS) of drug substances (especially Paclitaxel antitumoral and colchicinoid compounds). --isolation and spectroscopic identification of natural compounds from vegetable extracts by column chromatography.