ph3bJob Description /b /h3 pAgilent 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 /p pbAre 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 /bon bimproving quality of life. Then we are looking for you! /b /p pCome 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. /p pWe 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. /p pbYour main task will be: /b /p ul liCreate, manage, and ensure closure of daily Regulatory blocks /li liBecome an expert with the GTS tool handling Regulatory release of IVD products /li liCreate, train, and implement tools for accurate tracking of product changes /li liCollaborate with Global Regulatory Affairs ensuring regulatory assessments of changes is sought, obtained, and documented /li liOversight of Channel Partner business licenses and renewals /li liOversight of IVD registrations and renewals /li liCollaborate with Global Regulatory Affairs ensuring timely registration of IVD products and their renewals /li /ul h3bQualifications /b /h3 ul liA university degree in a relevant field such as Life-Science/Engineer/Law etc.



/li liSignificant regulatory experience with a solid understanding of IVD/medical device regulations and registration requirements. /li liAbility to interpret regulations and standards in relation to specific products. /li liExcellent interpersonal and communication skills in English /li /ul pIn 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. /p h3bWe offer: /b /h3 ul liAn independent job in collaboration with good colleagues, in a growth-orientated organization /li liA true commitment to work/life balance /li liAn opportunity to learn and grow in the field of Regulatory Affairs /li liAgilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Employee Assistance Program, Holiday, Company activities. /li /ul pPay range: /p p45.296,00 - 70.775,00 EUR per annum The position is classified at Levels 2 or 1 under the CCNL Terziario, distribuzione e servizi – Cod. H011, which defines minimum salary levels, pay progression, and working conditions /p h3bAdditional Details /b /h3 pThis job has a full time weekly schedule. It includes the option to work remotely. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and vantaggi information by country are available at: 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. /p h3bTravel Required: /b /h3 pOccasional /p h3bShift: /b /h3 pDay /p h3bDuration: /b /h3 pNo End Date /p h3bJob Function: /b /h3 pQuality/Regulatory /p /p #J-18808-Ljbffr

📌 Sr. International Regulatory Affairs Specialist - EMEA (Italia)
🏢 Agilent
📍 Italia