Clinical Reviewer Mdr/ivdr

vor 4 Monaten

Plattling, Deutschland CSA Group Vollzeit

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 Clinical Reviewer MDR/IVDR (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
The Clinical Reviewer will support the MD/IVD assessment team in the delivery of clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.
- These are your duties:_- To ensure that assessments conducted have properly examined and addressed the regulatory responsibilities of the manufacturer with respect to product clinical performance including alignment with state-of-the-art expectations and defended risk/benefit for the product. In this responsibility the CR is expected to formulate, maintain and improve clinical assessment procedures and protocols in line with both CSA Group and external Authority expectations-
- Responsible for developing and delivering up to date training to clinical assessors as well as running periodic calibration events for the clinical team-
- Support the Head of Medical Regulatory Services in demonstrating to the relevant authorities that appropriate clinical assessment procedures and protocols are in place and effective and that clinical assessment projects have been conducted and reviewed according to CSA Group procedures-
- Provide oversight and review of clinical data assessments performed by other deployed clinical staff (internal and external) in relation to customer compliance with relevant National and International Regulations and Norms-
- Support the Commercial team in the formulation and effort estimation for the clinical assessments of product on an as needed basis- What_
- _
- we_
- _
- expect_
- :_- University degree in medical or scientific university or polytechnic studies; or comparable professional knowledge-
- 5+ years of relevant clinical experience-
- Profound 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-
- Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under conformity assessment procedures-
- Strong interpersonal skills; self-starter; good decision-making skills and organizational skills-
- Ability to manage multiple clinical evaluations and changing schedules and deadlines with supervision-
- Excellent communication skills (verbal and written)-
- Strong conflict resolution skills to be able to handle difficult situations-
- Good command in German and English language skill written and oral. Any other European language beside German and English will be a benefit- What we offer:_- 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-
- Opportunities for constant training/learning-
- Permanent employment- Le Groupe CSA est un employeur qui souscrit au principe de l’égalité des chances; il s’engage à promouvoir la diversité, l’équité et l’inclusion. Nous interdisons toute forme de discrimination et de harcèlement fondée sur les motifs prévus par les lois applicables. Nous sommes une organisation où les possibilités sont fondées sur les compétences et les capacités, et où les différences sont respectées et valorisées. Veuillez communiquer avec nous à l’adresse _
- _
- si vous avez besoin d’une mesure d’adaptation dans le cadre du processus d’entretien._

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