Regulatory Affairs Specialist
As a Regulatory Affairs Specialist at GC Europe, you ensure that the organization at all times meets its legal obligations with regard to product registration in countries for which GC Europe is responsible, and to CE Marking with specific regard to transition from MDD to MDR. You are responsible for product-related information that is legally required to support the activities of the organization. You expand our “center of excellence” with regard to product registrations, where the expertise is not only used to ensure compliance, but also to anticipate trends and changes.
What is your mission?
- You ensure that all CE marking and registration documents (including compiling product technical file) are complete and up to date.
- You are responsible for product-related information that is legally required to support the activities of the organization.
- You perform Vigilance activities as required.
- You interface with Sales, Marketing and QA Departments to ensure PMS activities are conducted under regulatory supervision.
- You ensure that all mandatory legal information is available when needed, with due confidentiality.
- You are responsible for registration in non-EU countries for which GC Europe is responsible
Who are you?
- Master degree in Chemistry, Biology or equivalent life science / engineering
- Minimum 3 years of experience in the Medical device / Pharma / Life science industry
- Solid understanding of mandatory legal documents.
- Knowledge of ISO Standards (13485) (FDA CFR Title 21 desiderable).
- Practical knowledge of EU Medical Device Directive, Medical Device Regulation and relevant guidelines.
- Very good command of MS Office applications especially Excel, PowerPoint, Word.
- Excellent command of both written and spoken English (any other language is a plus).
- Result and quality oriented approach, customer focus, analytical thinking, self-determination, good communication skills, highly committed personality and a desire to achieve are required competencies.
- High flexibility in adapting to a fast pacing environment in the regulatory arena.
What do we offer you?
- A challenging job with potential for growth in an international and diverse company.
- A permanent contract with full time employment.
- Flexible hours.
- Competitive salary package including benefits (meal vouchers, hospitalization and group insurance).
- Stunning offices and a great company culture, based on respect and comradeship.
- An opportunity to contribute to a better, healthier world in collaboration with colleagues who are passionate about what they do.
Who are we?
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 is located at the Researchpark Haasrode in Leuven. GC Europe NV supports and leads our different sales offices and dealers. Our warehouse spreads our products to Europe and the Middle East. Next to this we produce some leading products for dental technicians.
When applying, be sure to upload your CV and motivational letter to your profile!