Myriam Desmet

Myriam Desmet Email and Phone Number

QA and RA manager @ Robovision
Brussels, BE
Myriam Desmet's Location
Brussels Metropolitan Area, Belgium
Myriam Desmet's Contact Details

Myriam Desmet work email

Myriam Desmet personal email

Myriam Desmet phone numbers

About Myriam Desmet

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

Myriam Desmet's Current Company Details
Robovision

Robovision

View
QA and RA manager
Brussels, BE
Website:
robovision.ai
Employees:
122
Myriam Desmet Work Experience Details
  • Robovision
    Qa And Ra Manager
    Robovision
    Brussels, Be
  • Health Care & Medical Devices Consulting
    Director
    Health Care & Medical Devices Consulting 2005 - Present
    Belgium
    • 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, …
  • Will Pharma
    Qa & Ra Manager, Prrc
    Will Pharma Jul 2020 - Present
    Wavre, 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
  • Biomodex
    Director Qa
    Biomodex Dec 2018 - Dec 2019
    Paris Area, France
    QMS 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
  • Diabeloop
    Director Regulatory, Quality & Clinical Affairs
    Diabeloop Aug 2016 - Oct 2018
    Région De Grenoble, France
  • Cellnovo Ltd
    Vice President Regulatory Affairs And Quality Affairs
    Cellnovo Ltd Jun 2015 - Aug 2016
    Paris, Wales, ...
  • St. Jude Medical
    Senior Manager Clinical Safety - International Division
    St. Jude Medical Jun 2012 - Aug 2015
  • Kimberly-Clark Healthcare
    Head Regulatory Affairs & Quality Assurance Emea
    Kimberly-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
  • Abv Healthcare
    Head Regulatory & Reimbursement Affairs
    Abv 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, …
  • Vexim Sas
    Head Regulatory & Clinical Affairs
    Vexim 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
  • Kyphon
    Regulatory Compliance Manager
    Kyphon 2005 - 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 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
  • Unamec
    Regulatory Affairs & Reimbursement Advisor
    Unamec 2002 - 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
  • Université Libre De Bruxelles
    Assistante En Economie De La Santé Et Politiques Et Systèmes De Santé
    Université Libre De Bruxelles 1995 - 2002
    Recherche: - 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
  • Clinique Notre-Dame De Grâce
    Infirmière Chef De Service Soins Intensifs
    Clinique Notre-Dame De Grâce 1993 - 1995
    Gestion et organisation de l'unité de Soins IntensifsGestion de l'équipe soignanteCoordination avec la Pharmacie et le Magasin de Matériel Médical
  • Cub Hôpital Erasme
    Infirmière
    Cub Hôpital Erasme 1983 - 1993
    Infirmière aux Soins Intensifs (6 ans)Infirmière instrumentiste au Bloc Opératoire (4 ans)

Myriam Desmet Skills

Medical Devices Regulatory Affairs Fda Iso 13485 Clinical Trials 510 K Clinical Research Regulatory Submissions Quality Assurance Cross Functional Team Leadership Strategy Pharmaceutical Industry Economics Vigilance Regulatory Requirements Product Launch U.s. Food And Drug Administration Sop Team Management Quality System Regulatory Strategy Quality Systems Quality Management Ce Marking Strategy Development Management Business Development Cro Management Product Development

Myriam Desmet Education Details

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?

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

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.