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

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

Job Description

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. For more information on Agilent, visit .

We are seeking a highly motivated Senior Regulatory Specialist (m/f/d) to join our Global Regulatory Affairs team. In this role, you will support new product introduction projects, develop regulatory strategies, and coordinate international submissions, product change notifications, and licensing requirements for IVD products .

Your responsibilities include ensuring products are received, licensed, and delivered in compliance with global regulatory and quality standards. You will provide support for international IVD registrations, prepare documentation for regulatory submissions, maintain licenses, develop compliance programs, monitor regulatory changes, lead cross-functional regulatory projects, and communicate with regulatory agencies and partners.

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

Qualifications

• Bachelor’s degree in Regulatory Affairs, Quality Assurance, engineering, or a related science field
• Several years of relevant experience in a regulated environment
• Knowledge of international registration processes
• Strong teamwork, communication, and project management skills
• Experience with QMS in the medical device industry
• Proficiency in English

Preferred Qualifications

• Knowledge of ISO 13485 and 14791 standards
• Experience with regulated products and IVD regulations

Additional Information

We offer competitive benefits, career development opportunities, an inclusive culture, and a dynamic work environment. The role involves 10% travel and is a full-time position with a flexible remote work option.

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