Myriam Desmet work email
- Valid
Myriam Desmet personal email
- Valid
- Valid
Myriam Desmet phone numbers
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).Specialties: Regulatory affairs, Quality Assurance, Clinical affairs, Medical affairs, Reimbursement, Business development, General Management, Strategy, Health Economic
-
Qa And Ra ManagerRobovisionBrussels, Be -
DirectorHealth Care & Medical Devices Consulting 2005 - PresentBelgium• RegulatoVry Affairs: o Registration of medical devices: Europe (CE: MDR), Australia, Asia, Latin-America, USA (510(k), PMA), Canada, Middle East, South Africa, … o Technical file management to ensure compliance with regulatory requirements: CER, risk management, PMS, ... 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, …)), audit of suppliers• Reimbursement: o Reimbursement dossiers in Europe, Asia, Australia, USA, …
-
Qa & Ra Manager, PrrcWill Pharma Jul 2020 - PresentWavre, Walloon Region, Belgium Quality management system review and maintenance to ensure compliance with ISO 13485:2016, MDD and MDR (including CAPA, NC, Dev, internal audits, suppliers audits, …) Full review of the technical files to ensure compliance with MDD and MDR requirements Project leader for the relaunch of a class III medical device: suppliers handling, production validation, technical file update: CE certificate maintained. Business development support: distributors handling, product registration worldwide Production: validation of a new warehouse, IQ, OQ, PQ, QA release -
Director QaBiomodex Dec 2018 - Dec 2019Paris Area, FranceQMS implementation, validation and maintenance (ISO 13485, 21 CFR Part 820)Technical file implementation and maintenance in compliance with MDD, MDR and FDA regulationsQA (and RA) strategy -
Director Regulatory, Quality & Clinical AffairsDiabeloop Aug 2016 - Oct 2018Région De Grenoble, France -
Vice President Regulatory Affairs And Quality AffairsCellnovo Ltd Jun 2015 - Aug 2016Paris, Wales, ... -
Senior Manager Clinical Safety - International DivisionSt. Jude Medical Jun 2012 - Aug 2015 -
Head Regulatory Affairs & Quality Assurance EmeaKimberly-Clark Healthcare May 2010 - Jan 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 AffairsAbv Healthcare Jun 2009 - Dec 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 AffairsVexim Sas 2008 - 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 ManagerKyphon 2005 - 2008Regulatory 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 departmentsClinical affairs: compliance with legislation and standards, relations with competent authorities and ethical committeesQuality: SOP's writing, preparation and follow-up of audits, complaints handling and coordinationMember of Eucomed, UNAMEC, follow-up of the GHTF's works -
Regulatory Affairs & Reimbursement AdvisorUnamec 2002 - 2005Belgium:- 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
-
Assistante En Economie De La Santé Et Politiques Et Systèmes De SantéUniversité Libre De Bruxelles 1995 - 2002Recherche: - médiation dans les hôpitaux - allocation optimale de ressources limitées (salles d'opération) - profil médical & financier des hôpitaux publics Bruxellois - utilisation des données médico-administratives pour la gestion des hôpitaux - dispositifs médicaux utilisés au quartier opératoire: coût >< financement - création de l'observatoire du cancer au VietNam - données médicales et leur utilisation en politique de santé en Europe (EuroMedData) - prise en charge des enfants gravement malades à Bruxelles - hospitalisation à domicile >< hospitalisation classiqueEnseignement: - Principes d'économie, organisation & financement des soins de santé - Législation, organisation & financement des soins en Belgique - Méthodologie d'enquêtes dans les institutions de soins: collecte & traitement des données socio-épidémiologiques - Utilisation des données médico-administratives au sein de l'hôpital
-
Infirmière Chef De Service Soins IntensifsClinique Notre-Dame De Grâce 1993 - 1995Gestion et organisation de l'unité de Soins IntensifsGestion de l'équipe soignanteCoordination avec la Pharmacie et le Magasin de Matériel Médical
-
InfirmièreCub Hôpital Erasme 1983 - 1993Infirmière aux Soins Intensifs (6 ans)Infirmière instrumentiste au Bloc Opératoire (4 ans)
Myriam Desmet Skills
Myriam Desmet Education Details
-
Santé Publique -
Statistiques -
Gestion -
Gestion -
Nursing -
Institut De Nursing Sainte-AnneNursing
Frequently Asked Questions about Myriam Desmet
What company does Myriam Desmet work for?
Myriam Desmet works for Robovision
What is Myriam Desmet's role at the current company?
Myriam Desmet's current role is QA and RA manager.
What is Myriam Desmet's email address?
Myriam Desmet's email address is my****@****ail.com
What is Myriam Desmet's direct phone number?
Myriam Desmet's direct phone number is (203) 058*****
What schools did Myriam Desmet attend?
Myriam Desmet attended Université Libre De Bruxelles, Université Libre De Bruxelles, Université Libre De Bruxelles, Université Libre De Bruxelles, Université Libre De Bruxelles, Institut De Nursing Sainte-Anne.
What skills is Myriam Desmet known for?
Myriam Desmet has skills like Medical Devices, Regulatory Affairs, Fda, Iso 13485, Clinical Trials, 510 K, Clinical Research, Regulatory Submissions, Quality Assurance, Cross Functional Team Leadership, Strategy, Pharmaceutical Industry.
Who are Myriam Desmet's colleagues?
Myriam Desmet's colleagues are Sopan Paranjape, Matthias Verstraete, Sam De Meyer, Maxim Claeys, Kate Richards, Bram Gilliaert, Yongju Kang.
Not the Myriam Desmet you were looking for?
-
-
-
Myriam Desmet
Belgium -
Myriam Desmet
Belgium
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial