Medical Device Regulatory Certifier - Plattling, Deutschland - CSA Group

CSA Group

Geprüftes Unternehmen

Plattling, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 immediate opportunity for a Healthcare Regulatory Certifier (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
The Healthcare Regulatory Certifier provides high quality certification services which meets the clients' needs in the most efficient and effective manner possible, while ensuring safe products are available in the public marketplace.

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 stateoftheart 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
Independently manages certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within time frames and cost deadlines.
Evaluates products against requirements of the national / international standards and precedent decisions
To support the Commercial team in the formulation and effort estimation for the clinical assessments of product on an as needed basis
Delivers assigned projects within agreed timescales
Reviews test data and reports

Participates in assessments

What we expect:
Bachelor's degree in technical, medical or scientific university or polytechnic studies; or-
Engineering Technology or Associates Degree with 5 years industry related experience; or-
Journeyman Electrician with 5 years industry related experience; or related technical field with 7+ years industry related 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 regulatory conformity assessment procedures-
Strong interpersonal skills; self-starter; good decision-making skills and organizational skills.-
Technically competent to evaluate all products, including new and unique products, with assistance of other technical staff as necessary-
Ability to manage multiple assessments and changing schedules and deadlines with supervision-
Demonstrates technical competence to review the work of others per divisional quality documents-
Demonstrates technical competence in two or more technical scopes-
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.-
Ability to travel as needed and/or with short notice (up to 15% travel)
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 p