Regulatory Affairs Expert for IVD Product Registration
1 month ago
At Agilent Technologies, we are committed to advancing the quality of life through innovative solutions. As a Regulatory Affairs Specialist, you will play a key role in coordinating and tracking international submissions, product change notifications, and registration of IVD products.
This is an excellent opportunity for a motivated professional with a solid understanding of IVD/medical device regulations and registration requirements. You will be responsible for supporting IVDR regulatory activities, including design history file review, IVDR strategy drafting, and requirements documentation preparation.
You will also collaborate with Global Regulatory Affairs to ensure timely registration of IVD products and their renewals. Additionally, you will oversee IVD registrations and renewals, and implement tools for accurate tracking of product changes.
As a successful candidate, you will have a university degree in a relevant field such as Life-Science/Engineering/Law etc. and significant regulatory experience. You will be able to interpret regulations and standards in relation to specific products, and possess excellent interpersonal and communication skills in English.
We offer a true commitment to work/life balance, an independent job in collaboration with good colleagues, and an opportunity to learn and grow in the field of Regulatory Affairs. The estimated salary for this position is approximately $85,000 - $110,000 per year, depending on location and experience.
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected categories under all applicable laws.
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Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeAgilent Technologies Inc. is a global leader in life sciences, diagnostics, and applied markets. We are seeking a highly motivated Regulatory Affairs Specialist to play a key role in coordinating International submissions, product change notifications, product release and licensing requirements, and registration of IVD products.About the RoleThis full-time...
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Regulatory Affairs Professional, IVD Expert
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Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeRegulatory Affairs Specialist RoleA Regulatory Affairs Specialist with expertise in IVD products is sought to coordinate international submissions, product change notifications, and registration requirements for Agilent's extensive IVD portfolio.The ideal candidate will support IVDR regulatory activities, implement tools for accurate tracking of product...
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Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeRole Overview:We are seeking a highly skilled Regulatory Affairs Specialist to join our Global Regulatory Affairs team. This individual will play a key role in coordinating and tracking International submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent's extensive IVD...
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