Senior International Regulatory Affairs Specialist – EMEA

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Agilent Technologies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🔬 Science

🧬 Biotechnology

💊 Pharmaceuticals

💰 $500M Post-IPO Debt on 2019-09

Science • Biotechnology • Pharmaceuticals

Agilent Technologies is a global leader in the field of analytical and laboratory instruments. The company offers a diverse range of products and solutions, including gas and liquid chromatography, mass spectrometry, lab supplies, and software and informatics. Agilent serves various industries, such as biopharma, food and beverage testing, clinical diagnostics, and environmental testing. Additionally, Agilent provides comprehensive services for lab management, maintenance, and instrument repair. They focus heavily on advancing science through sustainable solutions and supporting genomics, pathology, and cancer research with advanced technologies.

📋 Description

• 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.

🎯 Requirements

• 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. • Proven capability in analytical and critical thinking. • Collaborating across global teams. • Strong organization skills. • Ability to run multiple ongoing responsibilities. • Driving tasks through to completion.

🏖️ Benefits

• 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.