Sr. International Regulatory Affairs Specialist - EMEA

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Sr. International Regulatory Affairs Specialist - EMEA
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In this role you will support international regulatory submissions for IVD products, primarily in EMEA (non-EU). You’ll work within the Global Regulatory Affairs team to ensure timely registrations, renewals, and changes, while building expertise in regulatory release processes and tracking tools. You will collaborate across global teams to assess and document regulatory changes, and oversee partner licenses and registrations. This position offers growth in a collaborative, growth-focused environment with meaningful impact on product compliance.
Agilent Result Premio
Stock Purchase Plan
Life Insurance
Pension
Employee Assistance Program
Create, manage, and close daily Regulatory blocks
Become an expert with the GTS tool handling Regulatory release of IVD products
Create, train, and implement tools for accurate tracking of product changes




Collaborate with Global Regulatory Affairs ensuring regulatory assessments of changes are sought, obtained, and documented
Oversight of Channel Partner business licenses and renewals
Oversight of IVD registrations and renewals
Collaborate with Global Regulatory Affairs ensuring timely registration of IVD products and their renewals
Significant regulatory experience with a solid understanding of IVD/medical device regulations and registration xysqume requirements
Ability to interpret regulations and standards in relation to specific products
University degree in Life-Science/Engineer/Law or related field
Excellent interpersonal and communication skills in English
Proven ability in analytical and critical thinking
Experience collaborating across global teams, strong organization, and ability to manage multiple responsibilities and drive tasks to completion
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77zu1p