Regulatory Affairs Specialist, IVDR

Job Description

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. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

Are you an individual with knowledge in IVD or Medical Devices, looking for a new challenge in your career? A job where your actions will have an impact on improving quality of life. Then we are looking for you!

Come and join a highly collaborative environment where you will be part of our Global Regulatory Affairs team with the opportunity to be exposed to innovative IVD products across different regulatory classifications including hardware, software, and immunochemistry technologies.

We are searching for an 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.

Your main task will be:

• Support of 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
• Collaboration 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

This role can be remote, and you can be based anywhere in Europe or the US where Agilent has an entity.

Qualifications

• 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

In order to succeed the successful candidate will have proven capability in analytical and critical thinking, collaborating across global teams, strong organization skills, ability to run multiple ongoing responsibilities, and driving tasks through to completion.

We offer in Denmark:

• 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.

Option to Work Remote

Travel Required

Schedule

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