Regulatory Affairs Professional
il y a 1 semaine
**First things first**: Wat mag je verwachten binnen jouw takenpakket? Jij zal ervoor zorgen dat farmaceutische en medische producten voorzien zijn van de juiste, juridische licenties. Je hanteert een adviserende en coördinerende rol in verband met de goedkeuring en registratie van geneesmiddelen. Op de hoogte blijven van de nationale en internationale wetgevingen en richtlijnen is een belangrijk deel van jouw functie. Jij zorgt ervoor dat de producten van het bedrijf voldoen aan deze regels. Je zal steeds goede argumenten opstellen voor nieuwe productlicensies en zal wetenschappers en fabrikanten adviseren over wettelijke eisen. Wettelijke inspecties uitvoeren, onderzoeksresultaten interpreteren, contact onderhouden en presentaties geven voor regelgevende instanties, zijn ook onderdeel van jouw takenpakket. Ook de leidinggevende zal je regelmatig adviseren op het gebied van de kwaliteit en veiligheid van de producten. Je zal registratiedossiers conform de geldende richtlijnen gaan voorbereiden, opstellen, indienen (met eventuele samenwerking met externe partners) en opvolgen. De ontwikkelingen op gebied van de wettelijke regelgeving zal je ten allen tijde blijven opvolgen.
Academic Master
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Regulatory Affairs Expert
Il y a 3 mois
Mechelen, Belgique Telenet Temps plein**Your team** The Regulatory Affairs Expert is a member of the Tribe Legal & Regulatory. Under the supervision of the Director Regulatory & Compliance, the Regulatory Affairs Expert provides regulatory advice, representation and support. This in relation to a broad range of regulatory topics, focused on the services and products of Telenet and companies in...
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Regulatory Affairs Expert
Il y a 7 mois
Mechelen, Belgique Telenet Temps pleinAs a member of our Legal & Regulatory Tribe the **Regulatory Affairs Expert **provides regulatory advice, representation, and support in relation to broad range of regulatory topics, focused on the services and products Telenet, as well as companies Telenet has invested in, provides to customers or procures from other parties. **Your responsibilities as a...
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Regulatory Affairs Specialist
il y a 2 semaines
Mechelen, Belgique Pharmalex Temps plein**We are growing, grow with us!** Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any...
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Regulatory Affairs Expert
il y a 2 jours
Mechelen, Belgique Telenet Temps plein**Job purpose** As a member of our Legal & Regulatory Tribe the **Regulatory Affairs Expert **provides regulatory advice, representation, and support in relation to broad range of regulatory topics, focused on the services and products Telenet, as well as companies Telenet has invested in, provides to customers or procures from other parties. **Key...
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Regulatory Affairs Associate
il y a 1 semaine
Mechelen, Belgique Oxford Global Resources Temps plein**Regulatory Affairs Associate**: - Location: Mechelen - Contact: Aurore Munaut - Job type: Contract - Contact phone: +32 10 68 53 31 - Industry: Life Sciences, Clinical Research As Regulatory Affairs Associate, you are responsible to manage and ensure that all regulatory requirements pertaining to clinical research are fulfilled. **Responsibilities** -...
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Regulatory Affairs Specialist
Il y a 7 mois
Mechelen, Belgique Nipro Europe Group Companies Temps plein**About the job**: As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our...
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Regulatory Affairs Officer
il y a 1 semaine
Mechelen, Belgique Nipro Europe Group Companies Temps pleinAs a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our European headquarters...
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Manager Regulatory Affairs
Il y a 3 mois
Mechelen, Belgique Alcon Temps pleinRA QA Manager - Responsible Person GDP At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to...
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Regulatory Affairs and Quality Assurance Vice President
il y a 1 jour
Mechelen, Belgique Nipro Europe Group Temps pleinRegulatory Affairs and Quality Assurance Vice President - Mechelen - Nipro Europe Group The Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance will lead the RA/QA/CA team within Nipro Medical Europe, ensuring compliance with quality and regulatory requirements for medical devices. This role is responsible for ensuring that NME...
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Regulatory Affairs and Quality Assurance Vice President
il y a 1 semaine
Mechelen, Flanders, Belgique Nipro Europe Group Temps pleinRegulatory Affairs and Quality Assurance Vice President - Mechelen - Nipro Europe GroupThe Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance will lead the RA/QA/CA team within Nipro Medical Europe, ensuring compliance with quality and regulatory requirements for medical devices.This role is responsible for ensuring that NME and...
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Consultant Regulatory Affairs Biocides
Il y a 9 mois
Mechelen, Belgique ENSUS CONSULTING Temps plein**Who are we?** **Ensus Consulting BV is a consulting and services firm operating at the interface between science, government and industry. We provide tailor-made Regulatory Affairs dossier management services to national and international customers covering all aspects of dossiers related to chemicals legislations (BPR, CLP, ED properties, etc.). In order...
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Regulatory Affairs Specialist
Il y a 7 mois
Mechelen, Belgique Nipro Europe Group Companies Temps pleinAs a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our European headquarters...
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Public Affairs Expert
Il y a 5 mois
Mechelen, Belgique Telenet Temps plein**Who is Wyre?** Welcome to Wyre, a **brand-new infrastructure company **in the market with the mission of successfully **rolling out **the **network of the future **. Wyre made its debut on **July 1, 2023 **, and was born from a **powerful collaboration **between **two leading companies**:Telenet and Fluvius **. At Wyre, we aim to create an inclusive...
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Senior Communication Specialist Lr Belgium
Il y a 7 mois
Mechelen, Belgique Wolters Kluwer Temps pleinWolters Kluwer is a global leader in professional information services. Professionals in the areas of legal, business, tax, accounting, finance, audit, risk, compliance and healthcare rely on Wolters Kluwer's market leading information-enabled tools and software solutions to manage their business efficiently, deliver results to their clients, and succeed in...
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Medical Director, RHeumatology
Il y a 2 mois
Mechelen, Belgique ICON Plc Temps pleinMedical Director, Rheumatology ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Rheumatologist to join our diverse and...
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Vp Ra/qa/ca
Il y a 7 mois
Mechelen, Belgique Nipro Europe Group Companies Temps plein**About the job** Reporting to the CEO, the Regulatory Affairs, Clinical Affairs and Quality Assurance VP (RAQACA) is responsible for leading the RA/QA/CA team within the Nipro Medical Europe (NME) organization, to assure compliance to all applicable quality and regulatory requirements for Medical Devices. The role holder will ensure that NME and its...
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QA/ra Officer
Il y a 4 mois
Mechelen, Belgique Nobel Biocare Temps pleinOperating Company: Nobel Biocare Location: Mechelen,Antwerpen,BE Date Posted: August 8, 2024 Req Number: R5020527 The global center of Software Development for Envista, Medicim, located in Mechelen, is world leader in innovative software solutions for the dental profession. We investigate, develop, maintain, and support innovative software solutions for...
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Associate Medical Director
il y a 1 mois
Mechelen, Belgique Galapagos Temps pleinPleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium. We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small...
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Associate Medical Director
il y a 1 semaine
Mechelen, Flanders, Belgique Galapagos Temps pleinPleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules,...
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Consultant Regulatory Affairs Biocides
Il y a 7 mois
Mechelen, Belgique ENSUS CONSULTING Temps pleinVereiste studies - Master: Studiegebied Toegepaste biologische wetenschappen - Doctoraat - Master: Studiegebied Wetenschappen Werkervaring - Geen ervaring Talenkennis - Frans (in beperkte mate) - Engels (zeer goed) - Nederlands (goed) Contract - Vaste Job - Contract van onbepaalde duur - Voltijds - Dagwerk Plaats tewerkstelling - Tervuursesteenweg 25...