Agilent Technologies is hiring an International Regulatory Affairs Specialist - EMEA (M/F/D) on a temporary contract. In this role, you will coordinate and track international submissions in the EMEA (non-EU) region for new IVD products, renewals, and changes. You'll join the Global Regulatory Affairs team to ensure timely registrations in a highly collaborative and growth-oriented environment.
What You'll Do
- 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.
- Maintain oversight of Channel Partner business licenses and renewals.
- Manage oversight of IVD registrations and renewals.
- Collaborate with Global Regulatory Affairs ensuring timely registration of IVD products and their renewals.
What We're Looking For
- A university degree in a relevant field such as Life-Science, Engineering, or Law.
- 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, and driving tasks through to completion.
Technical Stack
- GTS tool
Team & Environment
You will be part of the Global Regulatory Affairs team. This role offers an independent job in collaboration with good colleagues, within a highly collaborative and growth-orientated organization.
Benefits & Compensation
- Agilent Result Bonus
- Stock Purchase Plan
- Life Insurance
- Pension
- Healthcare
- Employee Assistance Program
- Holiday
- Company activities
- An opportunity to learn and grow in the field of Regulatory Affairs
- A true commitment to work/life balance
Work Mode
This role operates on a hybrid work mode.
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.
