Requirements: English
Company: GC Europe
Region: Leuven , Flanders
GC Corporation was founded in 1921 in Japan and has developed itself into one of the most prominent companies in the development, production and distribution of a very wide range of dental products. Since 1972 GC Europe NV, our European Headquarter is located at the Researchpark Haasrode in Leuven. GC Europe NV supports and leads our different sales offices and supports authorized dental dealers. Our warehouse distributes our products throughout Europe, Middle East and Africa. Additionally, we offer state of the art products and systems for dental technicians. We are currently looking for a:
Regulatory Affairs Specialist
Your Mission
- Ensuring that the organization at all times meets its legal obligations with regard to:
- Product authorization in countries for which GC Europe is responsible.
- CE Marking with specific regard to MDR.
- Responsible for product- related information that is legally required to support the activities of the organization.
- Expanding center of excellence with regard to product authorizations, where the expertise is not only used to ensure compliance, but also to anticipate trends/changes.
- All this in line with the policy of GC Europe.
Main responsibilities:
- Manage and improve products authorization process in targeted non-EU countries, by preparing and submitting technical documentation dossier collaborating with involved stakeholders.
- Ensuring that all CE marking and authorization documents (including compiling product technical file) are complete (up to date) and supporting other RA associates within the team for the product lifecycle management, including post market activities (PMS, PSUR, SSCP, Vigilance, etc).
- Responsible for product-related information that is legally required to support the activities of the organization.
- Interface with Sales Department and local agencies to establish registration strategy in selected markets.
- Ensuring that all mandatory legal information is available when needed, with due confidentiality.
- 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 GC Europe to them.
- Support and eventually coordinate targeted projects like EUDAMED data management, EU National Databases, etc.
Requirements:
- Preferable degree in Regulatory, Public Health, Politics, Business and Economics, Life or Clinical sciences.
- Minimum 2 years of experience in the Medical device / Pharma / Life science / Food industry, and related Regulations and Guidelines.
- Regulatory and/or Quality Assurance experience with its mandatory compliance documents is desirable.
- Previous experience in product authorization in non-EU markets will be considered.
- Fluency in using IT systems, like Web based/MS Office applications, ERPs, advanced user Excel is a plus.
- Methodical and resilient when it comes to managing repetitive administrative work.
- Process and policy oriented, analytical thinking, able to manage policies, procedures and databases.
- Customer focus, self-determination, autonomous and self-supporting.
- High flexibility and resilience in adapting to a fast-pacing regulatory environment.
- Excellent command of both written and spoken English (any other language will be considered).
- Good verbal and written communication skills, ability to interface with different cultures and external bodies.
We offer you:
- Challenging job in a growing international company.
- Multicultural environment.
- Full time employment with a contract for an indefinite period.
- Flexible hours.
- Competitive salary including benefits (meal vouchers, hospitalization and group insurance).
Interested?
Dont hesitate to send your CV and motivational letter to hr.gce@gc.dental
In case of questions, please contact our HR department through +32 16 74 13 18
GC is an equal opportunity employer that evaluates applicants regardless of their race, nationality, gender, age or disability.
We welcome candidates from all backgrounds, and actively promote diversity in the workforce.