Experience

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  Aleva Neurotherapeutics SA

  • Switzerland
  • Medical Equipment Manufacturing
  • 1 - 100 Employee

  • Regulatory and Clinical Affairs Director

    • Jan 2012 - Dec 2023

    •Management of Regulatory & Clinical Affairs activities for neuromodulation active implantable devices (class III)Main RA activities:• Obtained the CE-mark for a neuromodulation active implantable device under AIMDD: Managed the construction of the Technical Documentation; Agreed with the NB the schedule of submission; Led the team to answer questions; CE certification was obtained in December 2019.• Managed since 2022 the transition to MDR certification of the directSTIM DBS System: Agreed the schedule of transition with the NB; Managing the construction of the MDR-compliant Technical Documentation.• Obtained FDA IDE approval for the neuromodulation active implant, with guidance from a consultant acting as Correspondent. Aleva is the Study Sponsor and US Agent. Application included a Pre-Submission, then IDE application, then SIRs and meetings with FDA, then an IDE amendment. IDE was approved in February 2022.• Managed interaction with Notified Body and National Competent Authorities • Managed Post Market Surveillance and materiovigilance notifications• Person Responsible for Regulatory Compliance• Implementation of the Clinical Evaluation Process, PMS procedures and documents (e.g, CEP-CER, PMS and PMCF plans, PSUR, PMCFER)• Managed Risk Management process and documentation per ISO 14971• Performed internal audits in an ISO 13485-certified QMSDesign and Management of three clinical studies (per ISO 14155)::• A first-in-man intraoperative study for a directional deep brain stimulation lead. Thirteen patients tested between Dec 2012 and Nov 2013, showing benefits of directional stimulation• A first-in-man intraoperative study for a recording/stimulation diagnostic device for the brain.• A PMCF multicenter study since 2021, to obtain clinical data on safety and performance of a neuromodulation active implantable device.

  • Clinical Affairs Manager

    • Oct 2009 - Dec 2011

    • Designed strategy to obtain clinical proof-of-concept for a directional deep brain stimulation lead.• Designed first-in-man intraoperative study protocols for two different cranial implants • Assessed different regulatory roadmaps for CE-mark, and organized a Regulatory Pathway review by Notified Body for the initial design of a directional deep brain stimulation lead.• Review of Risk analyses per ISO 14971 with manufacturer of investigational devices.

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  • Consultant on Market Research for Medical Technology

    • Jan 2007 - Jul 2007

    Market analysis and market research for Medical Technology.

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  Medtronic

  • Marketing Project Manager

    • 2004 - 2006

    - Designed Marketing plan for the launch of a cardiac pacemaker. - Led European surveys of cardiologists and surgeons to understand their needs and drivers- Led the European launch of catheters for cardiac resynchronization.- Designed price guidelines for heart valves

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  Haemonetics

  • United States
  • Medical Equipment Manufacturing
  • 700 & Above Employee

  • Marketing Manager Red Cell Europe

    • 2001 - 2003

    • Responsible for developing business plans and marketing tools to help European subsidiaries increase sales of red cell collection equipments • Developed clinical validation protocols and designed training programs for Market introduction of equipment to collect red cells.

  • UK Business Manager

    • Jan 2000 - Sep 2001

    • Led the business development of Haemonetics in the UK and RoI, heading a team of 3 sales reps and 3 engineers.• Re-established the company as a competent supplier for the English National Blood Services within 18 months.

  • Marketing and Product Support Manager

    • 1999 - 2000

    • Responsible for maintaining and improving Red Cell collection product line, while defining the specifications of new products.• Created training course to introduce Total Quality Management tools (e.g. 7-Step Problem Solving, Lean thinking) in the European subsidiaries.

  • Product Development Manager

    • 1995 - 1999

    • Led a team of engineers for the development and clinical validation of new blood cell collection protocols for the European market.• Co-invented and patented an automated pump apparatus to filter red cells allowing automated monitoring of filtration.