Senior International Regulatory Affairs Specialist – EMEA

This is a fully remote position, open to applicants in Italy.

📋 Description

• Develop, oversee, and ensure resolution of daily Regulatory blocks.

• Become proficient in utilizing the GTS tool for managing the Regulatory release of IVD products.

• Design, educate, and implement tools for precise tracking of product modifications.

• Work in conjunction with Global Regulatory Affairs to ensure that regulatory evaluations of changes are requested, acquired, and recorded.

• Supervise Channel Partner business licenses and their renewals.

• Manage IVD registrations and their renewals.

• Collaborate with Global Regulatory Affairs to guarantee prompt registration of IVD products and their renewals.

⛳️ Requirements

• A university degree in a relevant discipline such as Life Science, Engineering, Law, etc.

• Extensive regulatory experience with a comprehensive understanding of IVD/medical device regulations and registration criteria.

• Capability to interpret regulations and standards in relation to specific products.

• Exceptional interpersonal and communication skills in English.

• Demonstrated ability in analytical and critical thinking, collaboration across global teams, strong organizational skills, the capacity to manage multiple ongoing responsibilities, and driving tasks to successful completion.

🏝️ Benefits

• Agilent Result Bonus

• Stock Purchase Plan

• Life Insurance

• Pension

• Healthcare

• Employee Assistance Program

• Holiday

• Company activities