Regulatory Affairs Specialist
2 weken geleden
- Manage and ensure compliance with regulatory requirements for the product portfolio.
- Provide regulatory affairs (RA) support for research and development Key activities/main objectives
- Manage and ensure compliance with regulatory requirements for the product portfolio.
- Provide regulatory affairs (RA) support for research and development (R&D) projects and product modifications.
- Maintain up-to-date technical documentation for the SCI product lineup.
- Assess product conformity and oversee the conformity assessment process.
- Offer technical and RA expertise for the approval of medical devices.
- Facilitate the global registration process for all products.
- Stay informed about and communicate relevant changes in regulatory legislation and guidelines.
- Report to the RA director or designated authority.
- Master's Degree or equivalent experience in Engineering, Pharmacy, Chemistry, or a related life science field.
- Familiarity with relevant regulations such as MDR, FDA 21 CFR 820, SOR98-282, and TGA, as well as guidelines like FDA, MDGG, and MEDDEV.
- Knowledge of applicable ISO standards.
- Proficiency in project management.
- Strong verbal and written communication abilities.
- You are available for 32-40 hours.
- You live close to Amersfoort.
- You have a valid working permit.
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Regulatory Affairs Specialist
4 dagen geleden
Utrecht, Nederland Undutchables VoltijdKey activities/main objectives Manage and ensure compliance with regulatory requirements for the product portfolio. Provide regulatory affairs (RA) support for research and development Key activities/main objectives Manage and ensure compliance with regulatory requirements for the product portfolio. Provide regulatory affairs (RA) support for research and...
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Regulatory Specialist and Senior Specialist
3 dagen geleden
Utrecht, Nederland Undutchables VoltijdManage and ensure compliance with regulatory requirements for the product portfolio. Provide regulatory affairs (RA) support for research and development (R&D) projects and product modifications. Offer technical and RA expertise for the approval of medical devices. Master's Degree or equivalent experience in Engineering, Pharmacy, Chemistry, or a...
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Senior Director, Regulatory Affairs Strategy-EU/RoW
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Director, Global Medical Affairs Strategy
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Product Development Scientist Medical Devices
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Product Development Scientist Medical Devices
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Utrecht, Nederland Oxford Global Resources VoltijdWe are looking for passionate product developer within medical divides. You well work on developing cutting-edge solutions utilizing synthetic bioresorbable materials and therapeutic proteins. Job Description: We are seeking a talented and motivated Product Development Scientist with expertise in medical devices to join our dynamic team. As a Product...
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RA Specialist
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Coördinator Data
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Coördinator Data
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Utrecht, Nederland Undutchables VoltijdThe Tender and Contracts team is responsible for securing and managing agreements to supply their products to European hospitals. As a tender and contract specialist you are the "spider in the web" and liaise with a number of internal departments including legal, product development, regulatory affairs and finance. They join forces with the local sales teams...
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Tender & Contracts Coordinator | German
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Medical Director
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Tender & Contracts Coordinator | German
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Utrecht, Nederland Undutchables VoltijdJob description The Tender and Contracts team is responsible for securing and managing agreements to supply their products to European hospitals. As a tender and contract specialist you are the "spider in the web" and liaise with a number of internal departments including legal, product development, regulatory affairs and finance. They join forces with the...
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Tender & Contracts Coordinator | German
3 weken geleden
Utrecht, Nederland Undutchables VoltijdJob description The Tender and Contracts team is responsible for securing and managing agreements to supply their products to European hospitals. As a tender and contract specialist you are the "spider in the web" and liaise with a number of internal departments including legal, product development, regulatory affairs and finance. They join forces with the...
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