Claude Rousselle

FAQ About Claude Rousselle

• What is Claude Rousselle's address?

  Claude Rousselle is located at
  Belgium

• What is Claude Rousselle's job title?

  Claude Rousselle is a
  En charge pour toute l'Europe du support Vigilance ( FSCA et FSN) et en charge du Quality Management system mis en place pour la filiale France/Benelux. - Organisation et management de conferences telephoniques et de reunions avec les fabricants et le representant autorise. - Evaluation des mesures correctives prises (FSCA – Field Safety Corrective Action) par les fabricants (retrait de lot, de produit information/recommandation produit). - Cooperation avec les autres autorites competentes du monde entier, echange d’informations. - Connaissance solide de la directive europeenne sur les DMDIV (98/79/CE), des guidelines MEDDEV relatifs au systeme de vigilance applique aux DMDIV et des normes ISO 9001 & 13485 concernant les standards de management de la qualite pour les dispositifs medicaux. - Support a la notification des produits marques CE aux autorites competentes Europeennes. Je fais partie depuis octobre 2010 de l'INTERNATIONAL REGULATORY AFFAIRS AND COMPLIANCE DEPARTMENT de la maison mere IMMUCOR INC .Support europeen a la mise en place d'un systeme de management de la qualite harmonise au niveau mondial Auditeur interne QMS pour tous les affilies europeens - Allemagne - Italie - Espagne - Portugal -UK - Management of the QMS for France and Benelux affiliates. - Good knowledge of the CE directive on IVDMD (98/79/CE), MEDDEV guidelines regarding the medical devices vigilance system. - Support of the vigilance system ( FSN, FSCA) for All ECA. - Organization of conference calls between Manufacturer and Authorized Representative in Europe in order to ensure follow-up of the FSN and Corrective Actions status. - Collaboration with the Competent Authorities in the rest of the world. - Notification support to IVD Devices. Design and review supports for Techinical files before submission to Notify Body and Competent Authority - Internal QMS auditor for European Affiliates Italy Spain Portugal Germany UK No Industry Available

• What industry does Claude Rousselle currently work in?

  Claude Rousselle currently works in the
  No Industry Available

• What is Claude Rousselle's area of expertise?

  Claude Rousselle specializes in
  En charge pour toute l'Europe du support Vigilance ( FSCA et FSN) et en charge du Quality Management system mis en place pour la filiale France/Benelux. - Organisation et management de conferences telephoniques et de reunions avec les fabricants et le representant autorise. - Evaluation des mesures correctives prises (FSCA – Field Safety Corrective Action) par les fabricants (retrait de lot, de produit information/recommandation produit). - Cooperation avec les autres autorites competentes du monde entier, echange d’informations. - Connaissance solide de la directive europeenne sur les DMDIV (98/79/CE), des guidelines MEDDEV relatifs au systeme de vigilance applique aux DMDIV et des normes ISO 9001 & 13485 concernant les standards de management de la qualite pour les dispositifs medicaux. - Support a la notification des produits marques CE aux autorites competentes Europeennes. Je fais partie depuis octobre 2010 de l'INTERNATIONAL REGULATORY AFFAIRS AND COMPLIANCE DEPARTMENT de la maison mere IMMUCOR INC .Support europeen a la mise en place d'un systeme de management de la qualite harmonise au niveau mondial Auditeur interne QMS pour tous les affilies europeens - Allemagne - Italie - Espagne - Portugal -UK - Management of the QMS for France and Benelux affiliates. - Good knowledge of the CE directive on IVDMD (98/79/CE), MEDDEV guidelines regarding the medical devices vigilance system. - Support of the vigilance system ( FSN, FSCA) for All ECA. - Organization of conference calls between Manufacturer and Authorized Representative in Europe in order to ensure follow-up of the FSN and Corrective Actions status. - Collaboration with the Competent Authorities in the rest of the world. - Notification support to IVD Devices. Design and review supports for Techinical files before submission to Notify Body and Competent Authority - Internal QMS auditor for European Affiliates Italy Spain Portugal Germany UK

• Which languages does Claude Rousselle speak? 

  Claude Rousselle speaks the following languages:
  No languages available.

• Which industries has Claude Rousselle previously worked in?   

  Claude Rousselle has prior experience in the following industries:
  No prior industries available.

• What is Claude Rousselle’s work experience?  

  Claude Rousselle has the following professional experience:
  No professional experience available. .

• How can I find Claude Rousselle on LinkedIn?  

  You can view Claude Rousselle’s
  LinkedIn profile at LinkedIn URL.

• What are Claude Rousselle’s work email addresses?  

  Claude Rousselle’s work email addresses are
  [email protected].

• What company does Claude Rousselle work for?  

  Claude Rousselle works at
  No Industry Available