Sara Finocchietti has 15 years of experience in the medical device industry, having lived in multiple European countries and Japan. Her career started in public research developing innovative medical devices as well as providing clinical and regulatory strategy for market access in Europe. Her previous experiences include working as a Clinical Affairs Manager at a French manufacturer with a full orthopedic portfolio, defining the strategy to transition to the EU’s Medical Device Regulation (MDR).

Sara has a keen interest in new technologies and innovation. She has extensive experience working within cross-functional and cross-cultural teams.

CORE COMPETENCIES

• Develop product strategies for medical devices to address clinical, regulatory and business needs
• Provide clinical strategies for innovative medical devices in order to make them attractive for acquisitions and/or external investments
• Develop regulatory strategies for clinical investigations and other studies (retrospective data collections, surveys) across Europe
• Develop, write and present submission information to European competent authorities, submission issues, meetings and supplements
• Present on industry panels and workshops to discuss clinical and regulatory strategies in Europe
• Provide ad-hoc training on MDR and Medical Device Coordination Group (MDCG) guidance
• Manage and execute global clinical studies

RECENT PROJECTS

• Clinical strategy for the planned indication extension on a cardiology device in the EU, UK and U.S.
• Regulatory and clinical strategy for an early stage device for measuring colic transfer time
• MDR clinical strategy and survey development for few class IIa and IIb devices CE marked under MDD