Regulatory affairs director Jobs in Bogen
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Regulatory affairs director • bogen
Zuletzt aktualisiert: vor 4 Tagen
Nous avons besoin de vous pour former une équipe de calibre mondial.Les activités du Groupe CSA reposent sur l’atteinte d’un idéal : rendre le monde meilleur, plus sûr et plus durable.Cet ideal est...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Healthcare Regulatory Project Planner (f / m / d)
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German Speaking Video Content Analyst in Lisbon
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Therapy Development Manager DACH
Edwards LifesciencesGermany, Bayern, RemoteHomeoffice
Vollzeit
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Healthcare Regulatory Project Planner (f / m / d)
CSA GroupPlattlingVor 30+ Tagen
Anstellungsart
- Vollzeit
StellenbeschreibungBachelor degree in technical, medical or scientific university or polytechnic studies or comparable professional knowledge 4+ years of relevant experience in management system certification in the field of medical devices Knowledge of global medical device conformity assessment programs (e.g., MDSAP, TCP, JPAL, HKMDACS, UKCA, FDA) Knowledge of the relevant regulations, directives and guidelines for certification of MD / IVD devices (Regulations (EU) 2017 / 745 and2017 / 746), relevant MDCGs as well as the role of the Notified Body Strong interpersonal skills; self-starter; good organizational skills. Ability to manage multiple clients and changing schedules and deadlines with supervision Excellent communication skills (verbal and written) Strong conflict resolution skills to be able to handle difficult situations Qualification as management system auditor in the healthcare sector is a benefit Technical competence in 2 or more main technical areas (IAF MD9) are a benefit Good command in German and English language skill written and oral. Any other European language beside German and English will be a benefit. Flat hierarchies in a professional and intercultural corporate environment Opportunity to work from home and flexible working hours Attractive tasks, exciting projects and the opportunity to contribute your own ideas Fitness and health program for a relaxed balance to the daily work routine Lease a Bike Company pension plan Other Corporate Benefits
Statut d'emploi : Regular
Type d'heures : Full time
Nous avons besoin de vous pour former une équipe de calibre mondial
Les activités du Groupe CSA reposent sur l’atteinte d’un idéal : rendre le monde meilleur, plus sûr et plus durable.Cet ideal est au coeur de notre mission depuis 1919, année où nous avons élaboré notre première norme d’ingénierie sur les ponts ferroviaires. Aujourd’hui, près de 100 ans plus tard, le Groupe CSA compte plus de 3 500 normes, codes et produits connexes.
Le Groupe CSA, dont le siège social se trouve au Canada, est présent à l’échelle mondiale : il possède plus de 30 laboratoires et bureaux en Europe, en Asie et en Amérique du Nord. Il propose des services de mise à l’essai, d’inspection et de certification d’une vaste gamme de produits — des articles de maison aux technologies de pointe — pour veiller à ce qu’ils répondent à des exigences strictes en matière de sécurité, de performance et d’impact sur l’environnement.
Nos employés sont fiers que leur travail ait une incidence positive sur la vie des gens. Nous avons besoin de personnes comme vous pour poursuivre notre mission en ce sens.
Résumé du travail :
CSA Group Europe has an opportunity for a Healthcare Regulatory Project Planner (f / m / d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
The Regulatory Project Planner will perform in the Healthcare Regulatory Field of Management System Certification as the person responsible for technical planning of assessments based on the understanding of information from clients’ applications.
These are your duties :
- responsible for technical evaluation of applications including feedback to the client on completeness and plausibility of applications
- to ensure that assessments are planned and scheduled within the appropriate timeframe under consideration of all relevant technical aspects of the underlying certification programs
- to ensure that all required resources for compliant performance of an assessment are available
- to perform the review of clients’ applications under consideration of regulatory requirements of the underlying certification programs
- an interface position to the sales teams where needed and provide technical information on the offered programs as well as customer-specific information to cross-sell laboratory services where applicable
- to support the Head of Medical Regulatory Services in establishing and implementing the operation procedures towards towards application review and project planning as well as in demonstrating to the relevant authorities that appropriate procedures and protocols are in place and effective
- involved in the planning, preparation and demonstration of contents for auditor experience exchange and technical training events
- to liaise with customer in planning stage to ensure requirements of national / international standards are met without compromising confidentiality
What we expect :
What we offer :