Sr. International Regulatory Affairs Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dlrtv

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 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 experienced Regulatory Affairs Specialist to play a key role in coordinating and tracking international submissions mainly in the EMEA (non-EU)



for new products along with renewals and changes to existing registrations.
Your main task will be:
Create, manage, and ensure closure of 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 is 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
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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dlrtv