Senior Regulatory Specialist (m / f / d) - IVD

Agilent encourages 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. Want more information on Agilent? Check out !

We are searching for a highly motivated Senior Regulatory Specialist (m / f / d) to be part of our Global Regulatory Affairs team where you will play a key role in supporting new product introduction projects and developing regulatory strategies to help bring products to the global market , coordinating and tracking international submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent’s IVD products.

The position helps to ensure products are received, licensed, and delivered by Agilent are performed in accordance with global regulatory and quality standards and regulations. As a member of the Agilent Global Regulatory Team, you will provide support to business teams for IVD registrations internationally such as the following :

• Prepares document packages for regulatory submissions and listings to ensure alignment and compliance with local and regional registration requirements and company policies.
• Compile materials required in submissions, license renewal and annual registrations. Maintains export licenses within SAP software for IVD licenses along with addressing global trade holds.
• Develops and implements programs and processes to ensure that company products are safe, legal, and meet customer expectations for compliance with national / regional / global regulations.
• Problem solve and raise regulatory and compliance issues to senior management as necessary.
• Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations) and anticipate, assess, and communicate changes to keep internal stakeholders updated on potential risks and opportunities that could impact ongoing and future projects.
• Leads regulatory projects requiring coordination with other functions, such as Legal, Marketing and Project Management along with Agilent distributor partners.
• Support regulatory impact assessments for change controls for changes that are currently registered.
• Coordinate preparation of product documentation needed for obtaining regulatory permits, licenses, and registrations.
• Consult with regulatory agencies as required to obtain interpretation and guidance on regulations as they apply to Agilent products.
• Communicate with Agilent Channel Partners regarding registrations and change assessments.

This position is preferably based in our Waldbronn office in Germany (hybrid model), but can also be based anywhere in Europe where Agilent has an entity.

Qualifications

Preferred Qualifications

We offer :

We look forward to receiving your application in English.

Agilent regularly receives awards as one of the best employers in the world : Awards | Agilent Technologies

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 : Agilent 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.

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