Regulatory Specialist Mea

il y a 2 jours

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 MEA**

**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.
- 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), as well as managing vigilance and post market activities in target non-EU countries.
- Manage notification to non-EU databases (e.g., SFDA, Swissdamed, MHRA) and maintain data up-to-date.
- Manage and maintain up-to-date regulatory clearance status in GC Europe internal database.
- Manage and maintain activity related KPI’s and report to management.
- 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 French, Arabic, Russian, 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.
- Remote working.
- Competitive salary including benefits (meal vouchers, hospitalization and group insurance).

**Interested?**

**Questions?

  • Regulatory Affairs Specialist

    il y a 1 semaine

    Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...

  • Regulatory Affairs Specialist

    il y a 2 semaines

    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...

  • Regulatory Affairs Specialist

    il y a 2 semaines

    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...

  • Clinical Regulatory Affairs Specialist

    il y a 2 semaines

    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...

  • Clinical Regulatory Affairs Specialist

    il y a 5 jours

    Leuven, Belgique Gc Europe Ag 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...

  • Global Specialist Science and Regulatory Affairs

    il y a 2 semaines

    Leuven, Belgique AB InBev Temps plein

    Seniority Level: AB InBev is seeking a Science and Regulatory Affairs (SRA) Specialist for our Global SRA team in the Global Innovation & Technology Center (GITEC), in Belgium. At the heart of our dynamic global growth is a simple belief: nothing should come between incredibly talented people and an accelerated career. That is why we dream big. Why we look...

  • Regulatory Affairs Administrator

    il y a 2 semaines

    Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...

  • Regulatory Submissions Coordinator

    il y a 5 jours

    Leuven, Belgique Medpace, Inc. Temps plein

    Job Summary: Our clinical activities are growing rapidly, and we are currently seeking a full-time Regulatory Submissions Coordinator (Study Start Up Specialist) to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you...

  • Junior Quality Specialist

    il y a 2 semaines

    Leuven, Belgique QAELUM Temps plein

    We are currently looking for a junior Quality Specialist for our HQ in Belgium. Qaelum NV is a fast-growing medical software solutions provider caring about patient safety, efficiency and quality improvements in medical imaging environments. With our solutions, we are one of the market leaders in Europe and have installations all over the globe. We believe...

  • EHS Specialist: EMEA processes

    il y a 6 jours

    Leuven, Belgique Donaldson Temps plein

    Donaldson is committed to solving the world’s most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make...

  • IT Security Specialist

    il y a 4 semaines

    Leuven, Belgique GC Europe Temps plein

    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...

  • Senior Medical Sciences Specialist Oncology

    il y a 2 semaines

    Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...

  • Energy Sector Legal Specialist

    il y a 5 jours

    Leuven, Flandre, Belgique Michael Page Temps plein

    About the RoleWe are seeking a highly skilled Legal Counsel to join our dynamic team. As a trusted advisor, you will provide legal support to our Sales, Marketing, Customer Experience, and Operations departments on complex legal matters. Your expertise will be instrumental in ensuring the company's compliance with the legal and regulatory framework.Your Key...

  • Senior Medical Affairs Specialist Radiation Oncology

    il y a 3 semaines

    Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...

  • Contract Specialist

    il y a 2 semaines

    Leuven, Belgique Medpace, Inc. Temps plein

    Job Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Contract Specialist to join our Clinical Operations team. This position plays a key role in the study start-up and clinical trial management processes at Medpace. The Site Contract Specialist will play a key role in advancing the...

  • Paralegal Specialist

    il y a 4 semaines

    Leuven, Belgique Medpace, Inc. Temps plein

    Job Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Contract Specialist to join our Clinical Operations team. This position plays a key role in the study start-up and clinical trial management processes at Medpace. The Site Contract Specialist will play a key role in advancing the...

  • Legal Specialist

    il y a 4 jours

    Leuven, Belgique Medpace, Inc. Temps plein

    Job Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Contract Specialist to join our Clinical Operations team. This position plays a key role in the study start-up and clinical trial management processes at Medpace. The Site Contract Specialist will play a key role in advancing the...

  • ICT IAM Solution Specialist

    il y a 5 jours

    Leuven, Belgique imec Temps plein

    /ICT IAM Solution Specialist ICT IAM Solution Specialist Computer and IT - Leuven | Just now As an ICT IAM Solution Specialist you will focus on design & implementation of IAM domains. ICT IAM Solution Specialist  What you will do We are looking for an experienced and hands-on Identity and Access Management (IAM) specialist who possesses...

  • Clinical Affairs Specialist

    il y a 4 semaines

    Leuven, Belgique Materialise Temps plein

    Belgium (HQ) Quality The Position Materialise is a dynamic, high-tech company headquartered in Belgium, with offices worldwide. Founded in 1990, today we have over 2,300 employees around the globe. Materialise’s mission is to innovate for a better and healthier world through our software and hardware infrastructure and in-depth knowledge of additive...

  • QAra Assistant

    il y a 1 semaine

    Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...