Regulatory Affairs Specialist, IVDR
20 hours ago
Agilent is seeking a highly motivated Regulatory Affairs Specialist to 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 portfolio.
Key Responsibilities- Support IVDR regulatory activities, including design history file review, IVDR strategy drafting, and Requirements documentation preparation
- Implement tools for accurate tracking of product changes
- Collaborate with Global Regulatory Affairs ensuring regulatory assessments of changes is sought, obtained, and documented
- Collaborate with project team representatives for accurate tracking on project deliverables
- Oversight of IVD registrations and renewals
- Collaborate with Global Regulatory Affairs ensuring timely registration of IVD products and their renewals
- A university degree in a relevant field such as Life-Science/Engineer/Law etc.
- Significant regulatory experience with a solid understanding of IVD/medical device regulations and registration requirements
- Ability to interpret regulations and standards in relation to specific products
- Excellent interpersonal and communication skills in English
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise.
What We Offer- An independent job in collaboration with good colleagues, in a growth-orientated organization
- A true commitment to work/life balance
- An opportunity to learn and grow in the field of Regulatory Affairs
- Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Employee Assistance Program, Holiday, Company activities
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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Regulatory Affairs Specialist, IVDR
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Glostrup, Glostrup Kommune, Denmark Agilent Full timeAbout the RoleAgilent is seeking a highly motivated Regulatory Affairs Specialist to 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 portfolio.Key ResponsibilitiesSupport IVDR regulatory activities,...
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