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Summary

In addition to an experience as nurse (intensive care and operating theatre suite), I acquired a scientific experience (Health Economic and Policy and Health Systems Departments of the Free University of Brussels), before moving towards the medical devices industry, while starting with the Belgian Federation of manufacturers and distributors of medical devices (UNAMEC). I then joined Kyphon and Vexim and also created my own company of consultance (HCMDC). Since now more than 25 years, I approached the health cares under various aspects, from the hospital practice to the recording of implants in Asia while passing in particular by the lobbying near competent authorities and the coordination of clinical studies, without forgetting the files of refunding, the publications, the audits or the co-operation. I thus acquired a varied experience which enables me to approach many situations. I particularly appreciated the dynamic approach of young companies where the aspects of coordination and know-how are important as much than the adaptation and the negotiation. I thus wish to put my knowledge and my experience at the profit of dynamic structures (start-up or others).

Experiences

Current Experience


  • Since June 2012

  • Director
    Since January 2005
    • Regulatory Affairs: o Registration of medical devices: Europe (CE), Australia, Asia, Latin-America, USA (510(k), PMA), Canada, Middle East, South Africa, … o Vigilance, MDR, … o Environment, waste, REACH, … o Production: impact of new developments on the "regulatory" situation of the devices on the market (in progress and new) o Authorized representative function in Europe for non European companies • Clinical & Medical Affairs: o Clinical strategy o Publication strategy o Clinical coordination: from the definition of objectives to publications • Quality affairs: o SOPs: redaction and follow-up o Audits: preparation and follow-up (internal and external audits (ISO 13485, ISO CAN 13485, …)) • Reimbursement: o Reimbursement dossiers in Europe, Asia, Australia, USA, …

Past Experience

  • Head Regulatory Affairs & Quality Assurance EMEA
    May 2010 --- January 2012
    - Restructuration, development and implementation of the RA & QA department (team management, expertise development) - Global RA & QA strategy to support EMEA Business - QSM: review and improvement - External representation: reinforcement on external activities (standard committees, trade associations) in order to support business on long term

  • Head Regulatory & Reimbursement Affairs
    June 2009 --- December 2010
    • Regulatory Affairs: o Registration of medical devices: Europe (CE), Australia, Asia, Latin-America, USA (510(k), PMA), Canada, Middle East, South Africa, … o Vigilance, MDR, … o Environment, waste, REACH, … o Production: impact of new developments on the "regulatory" situation of the devices on the market (in progress and new) o Authorized representative function in Europe for non European companies • Clinical & Medical Affairs: o Clinical strategy o Publication strategy o Clinical coordination: from the definition of objectives to publications • Quality affairs: o SOPs: redaction and follow-up o Audits: preparation and follow-up (internal and external audits (ISO 13485, ISO CAN 13485, …)) • Reimbursement: o Reimbursement dossiers in Europe, Asia, Australia, USA, …

  • Head Regulatory & Clinical Affairs
    January 2008 --- January 2009
    • Regulatory Affairs: o 510(k) dossier and presentation to the FDA o Contacts with Health Canada o CE dossier o Follow-up of the national and international legislations • Clinical Affairs: Planning of 15 studies over 5 years: coordination, budget, contacts with investigators, statistical analysis, writing reports, strategy defined and adapted in collaboration of marketing and production, … • Medical Affairs: Publication strategy (journals, congresses), writing abstracts • Quality affairs: o SOPs: writing and follow-up o Audits:Preparation and follow-up o Complaints handling • Reimbursement: strategy

  • Regulatory Compliance Manager
    January 2005 --- January 2008
    Regulatory affairs: follow-up & analysis of the national and internation regulations, Registration files (LatAm, Asia, Europe), relations with competent authorities, documentation organization and management, authorized representative function, coordination with production, marketing and business development departments Clinical affairs: compliance with legislation and standards, relations with competent authorities and ethical committees Quality: SOP's writing, preparation and follow-up of audits, complaints handling and coordination Member of Eucomed, UNAMEC, follow-up of the GHTF's works

  • Regulatory Affairs & Reimbursement Advisor
    January 2002 --- January 2005
    Belgium: - Price files: assistance to the companies and defense of the dossiers (member of the price commission) - Reimbursement files: assistance to the companies, preparation and defense of the dossiers, nomenclature review (member of the implants commission) - Regulatory affairs: follow-up and analysis of the regulations, including new law projects (contacts with the Ministery of Health) Europe and OEU: follow-up of the regulations, membre of Eucomed, follow-up of the GHTF'w works


  • January 1995 --- January 2002


  • January 1993 --- January 1995


  • January 1983 --- January 1993

Knowledge

LinkedIn Assessment :
Regulatory affairsMedical Devices510 KEconomicsClinical trialsRegulatory submissionsRegulatory StrategyqualityQuality SystemsQuality Assurance (QA)Quality ManagementCE markingVigilanceStrategy DevelopmentFDAISO 13485SOPClinical researchRegulatory RequirementsSOP

Education

  • in from Université libre de Bruxelles in 2002
  • in from Université libre de Bruxelles in 1997
  • in from Université libre de Bruxelles in 1996
  • in from Université libre de Bruxelles in 1995
  • in from Université libre de Bruxelles in 1992
  • in from in 1983

Area / Region

Bruxelles, Belgique

Others

Driving License
  • Yes