Regulatory Affairs Specialist (m/w/d) in Breckerfeld

JR Germany; Breckerfeld; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

Une entreprise internationale leader dans le développement de dispositifs médicaux recherche un Spécialiste en Affaires Réglementaires à Breckerfeld. Vous serez responsable de garantir la conformité des produits aux règlements de l'UE, tout en participant à une culture d'entreprise collaborative et respectueuse offrant des opportunités de développement. Ce poste propose un contrat à durée indéterminée avec des horaires flexibles, une option de télétravail, et plusieurs bénéfices attrayants.

Leistungen

Horaires de travail flexibles

Régime de pension d'entreprise

Stationnement gratuit

Fruits et boissons gratuits

Plan de leasing de vélo JobRad

Coopération avec divers fournisseurs de services sportifs

30 jours de congés

Qualifikationen

• Expérience de 3 à 5 ans dans le secteur des dispositifs médicaux ou pharmaceutiques.
• Connaissance des directives et régulations sur les dispositifs médicaux.
• Allemand requis, anglais très bon niveau, autres langues appréciées.

Aufgaben

• Assurer la conformité des documents de marquage CE et de l'enregistrement des produits.
• Coopérer avec le département R&D pour développer des stratégies réglementaires.
• Rester informé des changements futurs concernant les procédures d'enregistrement.

Kenntnisse

Compétences analytiques

Orientation client

Communication

Gestion des politiques

Ausbildung

Diplôme en dentisterie, ingénierie ou sciences de la vie

Tools

MS Office

Systèmes ERP

Jobbeschreibung

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Regulatory Affairs Specialist (m/w/d) in Breckerfeld, breckerfeld

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Client:

GC Orthodontics Europe GmbH

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

29.06.2025

Expiry Date:

13.08.2025

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Job Description:

GC Corporation was founded in Japan in 1921 and has grown to become one of the leading companies in the development, manufacture and distribution of a very wide range of dental products. Since 1972, our European head office, GC Europe NV, has been located in Leuven, Belgium. The GC Group has several subsidiaries in Europe, whose development, manufacture and distribution of products for specific areas of dentistry and dental technology round off our product portfolio. Our warehouses distribute our products throughout Europe, the Middle East and Africa.

We are currently looking for a:

Regulatory Affairs Specialist (m/w/d) for our location in Breckerfeld.

• Ensuring that all CE marking and registration documents (including compiling product technical file) are complete and up to date, driving transition to MDR.
• Responsible for product-related information that is legally required to support the activities of the organization.
• Perform Vigilance activities as required.
• Interface with Sales, Marketing and QA Departments to ensure PMS activities are conducted under regulatory supervision.
• Cooperate with R&D department during product development stage to address regulatory strategies.
• Ensuring that all mandatory legal information is available when needed, with due confidentiality.
• Support EU central registration office for non-EU countries where site products are registered.
• Remaining up-to-date on (future) changes concerning registration procedures or regulations concerning medical devices and providing proactive advice in order to adapt the procedures and systems of company to them.
• Cooperate with all the relevant departments to make sure that products Technical Files remain compliant.
• Minimum 3-5 years of experience in the Medical device / Pharma industries / Life science.
• Degree in Dentistry, Engineering, Life Science and/or specific experience in Regulatory is expected.
• Previous experience in dental sector (Orthodontics, Dental consumable, Dental Laboratories, …) is recommended.
• Practical knowledge of EU Medical Device Directive, Medical Device Regulation and relevant guidelines.
• Knowledge of ISO 13485, ISO 14001, ISO 45001 and other relevant Standards.
• Solid understanding of mandatory legal documents.
• German language is required (mother tongue or very high level), very good command of both written and spoken English, other languages are a plus.
• Fluency in using IT systems, like Web based/MS Office applications, ERPs.
• Process and policy oriented, analytical thinking, able to manage policies, procedures and databases.
• Customer focus, self-determination, autonomous and proactive approach.
• High flexibility and resilience in adapting to a fast pacing regulatory environment.
• Good verbal and written communication skills, ability to interface with different cultures and external bodies.
• A challenging role in a growing international company in a multicultural environment with good development opportunities in Breckerfeld.
• Competitive salary & additional benefits (flexible working hours, company pension scheme, free parking, free drinks & fruit, JobRad bike leasing scheme, cooperation with various sports providers, etc.), as well as 30 days of holiday.
• Full-time employment with a permanent contract.
• Home office option.
• Great corporate culture based on respect and team spirit with regular team events.
• An opportunity to contribute to a better and healthier world in collaboration with colleagues (also at European level) who are passionate about their work.