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.