Regulatory Affairs Specialist

Il y a 6 mois

Leuven, Belgique GC Europe Temps plein

**GC Europe NV** is the European subsidiary of **GC Corporation**, a family-owned company with headquarters in Tokyo. It is one of the biggest suppliers of dental products with over 2300 employees all over the world and 4 production branches in Japan, the USA, China and Europe. We supply an entire range of consumer materials, equipment and facilities for dental offices and dental laboratories. **GC** is global market leader in glass ionomer cements and a well-established supplier in the sector of composites, cementation materials, impression materials as well as dental stones, investment materials and ceramics. **GC** has been recognized for over 25 years as a provider of consistently high product quality, featuring user-friendly handling and providing the best levels of customer service. We are currently looking within our Regulatory Affairs Department for an:
**Regulatory Affairs Specialist**

**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 transition from MDD to MDR.
- Product authorization in countries for which GC Europe is responsible
- CE Marking with specific regard to transition from MDD 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 Tasks**:

- 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 and up to date, following the product lifecycle from launch to obsolescence, and coordinating and executing all 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.

**Requirements**:

- Preferable degrees in Regulatory, Public Health, Politics, Business and Economics, Life or Clinical sciences
- Minimum 3 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
- 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 especially German 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?**

**Questions?

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