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

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.

• 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.

• 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.

GC ist ein Arbeitgeber für Chancengleichheit, der Bewerber unabhängig von Rasse, Nationalität, Geschlecht, Alter oder Behinderung bewertet. Wir begrüßen Kandidaten mit unterschiedlichem Hintergrund und fördern aktiv die Vielfalt in der Belegschaft. Auch Quereinsteiger-Bewerbungen sind willkommen.

Please send your complete application documents, stating your earliest possible starting date and salary expectations, (by email only) to: bewerbung.breckerfeld@gc.dental

GC Orthodontics Europe GmbH
Harkortstraße 2
58339 Breckerfeld, Germany

https://www.gc.dental/ortho/de