Regulatory Affairs Professional, IVD Expert
3 weeks ago
Regulatory Affairs Specialist Role
A 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 changes, and collaborate with Global Regulatory Affairs ensuring timely registration of IVD products.
This role offers a chance to work remotely from Europe or the US, leveraging Agilent's growth-oriented organization, with opportunities to learn and grow in the field of Regulatory Affairs.
Main Responsibilities:
- Coordinate international submissions, product change notifications, and registration requirements
- Support IVDR regulatory activities, including design history file review and strategy drafting
- Implement tools for accurate tracking of product changes
- Collaborate with Global Regulatory Affairs ensuring timely registration of IVD products
Requirements:
- University degree in a relevant field, such as Life-Science/Engineering/Law
- Significant regulatory experience with a solid understanding of IVD/medical device regulations
- Ability to interpret regulations and standards in relation to specific products
- Excellent interpersonal and communication skills in English
What We Offer:
- An independent job in collaboration with good colleagues
- 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.
Estimated Salary: 75,000 - 90,000 EUR per year, depending on location and experience.
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Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeAt 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...
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