Sr. International Regulatory Affairs Specialist - EMEA
Milan, Lombardy, Italy · Remote OK
$45k–$71k/yr
Senior$500M raised
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Skills: Regulatory Affairs, IVD, Medical Devices, Regulatory Submissions, Compliance
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Sr. International Regulatory Affairs Specialist - EMEA
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$45k–$71k/yr
Full-time
bachelor degree
Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Employee Assistance Program
Posted 13d ago
~40 hrs/week
Remote in Milan, Lombardy, Italy
Responsibilities
The specialist will coordinate and track international regulatory submissions for IVD products, primarily in the EMEA region. They will also manage regulatory blocks, oversee channel partner licenses, and ensure timely registration and renewals of products.
Requirements
Candidates must hold a university degree in a relevant field such as Life Science, Engineering, or Law. Significant regulatory experience with a solid understanding of IVD and medical device regulations is required.
Full job description
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 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 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:
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.
Pay range:
45.296,00 - 70.775,00 EUR per annum
The position is classified at Levels 2or 1 under the CCNL Terziario, distribuzione e servizi – Cod. H011, which defines minimum salary levels, pay progression, and working conditions
Additional Details
This 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 benefit information by country are available at: https://careers.agilent.com/locationsAgilent 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.
Agilent customers are finding new ways to treat cancer, ensure food, water, air, and medicine quality and safety, discover new drug treatments, research infectious diseases, and create alternative energy solutions for a greener planet. From start to finish, we have them covered with our vast product solutions and services portfolio.
Around the world, Agilent’s people bring innovations, technologies, and services to the forefront of science. Our teams design and manufacture a wide array of advanced analytical, research, and diagnostic solutions and tools for use inside and outside laboratories.
Additionally, the unique expertise of Agilent’s CrossLab and technical teams provides valuable insight and support to our customers, helping them fully optimize their laboratories and resources to better focus on what's important: bringing great science to life.
In fiscal 2022, Agilent Technologies generated revenue of (US) $6.85 billion.
Offices: 5301 Stevens Creek Boulevard, Santa Clara, CA 95051, US · Produktionsvej 42, Ejby, Capital Region 2600, DK · Hi-Tech City Road, Hyderabad, TS 500081, IN · 1 Yishun Ave 7, Singapore, Singapore 768923, SG · Calle Jose Echegaray, 8, Las Rozas de Madrid, Community of Madrid 28232, ES
How many Healthcare jobs are open in Milan, Italy right now?
There are currently 372 open healthcare positions in Milan, Italy listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Milan, Italy?
Companies currently hiring include Santagostino, Jupiter Medical Center, Abbott, Chiesi Italia, Humanitas Mater Domini, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Milan, Italy?
Yes — 177 of the 372 open healthcare positions offer remote or hybrid work (47 remote, 130 hybrid).
How do I apply for Healthcare jobs in Milan, Italy?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.