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 - 2017/07/21 - 

Director, Regulatory Affairs & Quality Assurance - EDAP Technomed Inc.



EDAP TMS ( www.edap-tms.com) is a pioneer and a market leader in Extracorporeal Shockwave Lithotripsy (ESWL) with the Sonolith ® range of devices. With Ablatherm® HIFU and its recently introduced Focal One ®, EDAP TMS is the leader in High Intensity Focused Ultrasound (HIFU) for the treatment of Prostate Cancer. Both technologies are based on ultrasound waves but their markets and contexts are distinct, and they therefore require specific marketing strategies.

The Company's business strategy is to capitalize on its expertise in therapeutic ultrasound and its position in urology to achieve long-term growth as a leader in the development, production, marketing and distribution of minimally-invasive medical devices for urological and other indications, primarily using HIFU and shock wave technologies.

In late 2015 the Company received FDA approval to begin marketing the Ablatherm HIFU technology for ablation of Prostate Tissue in the United States and for the last 18 months has been building momentum with installations of new systems and clinical performance which positions the technology well in the world’s largest marketplace.  In May 2017 the Centers for Medicare and Medicaid Services (CMS) established a new billing code for HIFU ablation of prostate tissue which applies to EDAP’s Ablatherm technology.


Based in Austin, Texas and reporting to the CEO of Americas, the Director Regulatory Affairs & Quality Assurance will manage the Quality and Regulatory systems at the company and conduct improvements/expand as needed. The activities of this role are critical for the growing and developing organization, insuring processes, systems and practices meet quality and regulatory requirements. The successful candidate will interface directly and indirectly with auditors, the FDA, and Authorized Representatives. This position will be a key member of a strong team that is passionate about the technology and company. We seek a proactive individual who produces real time solutions to situations on the ground, while planning and executing to insure the organization achieves its strategic goals.

Key Experience Requirements 

• Supporting or conducting the domestic clearance of class II and/or class III medical devices.
• Management and execution of Post Market Surveillance for domestic markets.
• Prior experience managing systems and processes for efficient vigilance reporting in the US.
• Demonstration of successful audit experience.
• Hands on, entrepreneurial style and demonstrated ability to work effectively in a small business culture.


• Serves as the company’s Management Representative.
• Investigates customer feedback and complaints regarding quality and implements corrective actions as required.
• Maintains and improves organizational post market surveillance and vigilance systems, collaborating with other members of management to insure effectiveness.
• Supports and manages regulatory audits, audit preparedness and readiness profiles.
• Supports and manages entity regulatory submissions for domestic clearances.
• Manages the inspection, testing, and evaluation of product quality and performance.  
• Writes training materials and conducts Quality and Regulatory System training for company personnel.  
• Visits and confers with vendors for auditing, qualification, verification of compliance and resolution of quality issues.
• Maintain current knowledge of, and compliance with, the full range of related quality systems, regulatory requirements, and related policies and procedures.
• Performs other related duties as assigned by management or as the situation dictates.


• Bachelor’s Degree
• Minimum of 5 years in the medical device industry or related GMP environment or equivalent, with responsible role for leading Regulatory and Quality projects
• Experience with Class II and/or III medical devices/ systems


• The US headquarters for the company and the position are based in Austin, Texas
• Compensation package depending on profile and experience



 - 7 Juin 2017 - 



EDAP TMS France est une société internationale, leader dans le domaine des thérapies non invasives, spécialisée dans la conception, la fabrication et la commercialisation d'équipements médicaux de haute technologie, basée à Vaulx-en-Velin. Dans un contexte de développement de nos activités, un poste en alternance est ouvert au sein de notre Direction Financière : nos services financiers interviennent dans un environnement exigeant et international, (groupe coté en Bourse (NASDAQ), Sarbanes-Oxley, reporting trimestriel, etc.).

Dans le cadre de votre alternance, vos missions seront les suivantes :

  • Contrôle de Gestion : vous assisterez le Contrôle de Gestion dans le cadre des clôtures trimestrielles et le processus budgétaire :
    - Analyse des dépenses par services
    - Suivi des coûts de garantie
    - Analyse de profitabilité par Business-Unit
    - Suivi et analyse des stocks
    - Suivi de dossier de projet R&D
  • Comptabilité : en support au service Comptabilité, vous intervenez sur les actions suivantes :
    - Suivi de la comptabilité Holding
    - Suivi des prévisions de Trésorerie
    - Revue de comptes pour les clôtures trimestrielles
  • Mise en œuvre d'un nouvel ERP : vous intervenez dans la mise en place des paramétrages et la reprise des historiques, avec contrôle de cohérence et respect des process financiers.

De formation comptable et/ou financière supérieure (bac+2 minimum), vous avez une première expérience, idéalement réalisée en alternance, en comptabilité, contrôle de gestion, ou en gestion de trésorerie. Vous désirez poursuivre vos études en alternance en vue du Diplôme de Comptabilité et de Gestion (DCG). Vous êtes curieux et avez envie d'apprendre, avec rigueur, polyvalence, autonomie et méthode. Vous avez impérativement une bonne maîtrise des outils informatiques (Pack Office). Vous maîtrisez l'anglais et vous connaissez les logiciels de Comptabilité et/ou contrôle de gestion. Le poste est à pourvoir à la rentrée Septembre 2017, pour une durée d'un an.

Ou envoyer votre candidature via le formulaire en ligne.