Descrizione dell'offerta
Sr. International Regulatory Affairs Specialist - EMEA
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 Bonus 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 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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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 Bonus 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 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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Candidatura e Ritorno (in fondo)
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