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Senior Regulatory Specialist (m/f/d) - IVD, Barcelona
Client: Agilent
Location: Barcelona, Spain
Job Category: Other
EU work permit required: Yes
Job Views: 1
Posted: 30.04.2025
Expiry Date: 14.06.2025
Job Description:
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. Want more information on Agilent? Check out !
We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team where you will play a key role in supporting new product introduction projects and developing regulatory strategies to help bring products to the global market. Your responsibilities include coordinating and tracking international submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent.
The position ensures products are received, licensed, and delivered by Agilent in accordance with global regulatory and quality standards and regulations. As a member of the Global Regulatory Team, you will support international IVD registrations, including:
* Preparing document packages for regulatory submissions and listings to ensure compliance with local and regional registration requirements and company policies.
* Compiling materials for submissions, license renewal, and annual registrations. Maintaining export licenses within SAP for IVD licenses and addressing global trade holds.
* Developing and implementing programs to ensure products are safe, legal, and meet customer expectations for compliance with regulations.
* Problem solving and raising regulatory issues to senior management as needed.
* Monitoring regulations and participating in discussions on regulation changes to update stakeholders on potential impacts.
* Leading regulatory projects involving coordination with Legal, Marketing, Project Management, and distributors.
* Supporting regulatory impact assessments for change controls.
* Preparing documentation for permits, licenses, and registrations.
* Consulting with regulatory agencies for guidance.
* Communicating with channel partners regarding registrations and change assessments.
This position is preferably based in our Waldbronn office in Germany (hybrid), but can be located anywhere in Europe where Agilent has an entity.
Qualifications
* Bachelor’s degree in Regulatory Affairs, Quality Assurance, engineering, or related science field
* Several years of relevant experience in a regulated environment
* Experience with international registrations
* Strong teamwork and leadership skills, effective across functions and geographies
* QMS experience for medical devices
* Proficient in English (written and spoken)
Preferred Qualifications
* Excellent communication, project management, and presentation skills
* Knowledge of design controls and standards (ISO 13485, 14791)
* Experience with regulated products, ISO standards, and IVD regulations
We offer:
* Core global benefits, plus bonuses, private healthcare, pension, stock plans, insurance (varies by country)
* Growth opportunities in an international company
* Cultural diversity and inclusion
* Independent role with supportive colleagues in a fast-paced, integrity-driven environment
* Exciting projects in a collaborative, agile culture
* Work-Life balance encouragement
* Permanent contract in a growing global company
We look forward to your application in English.
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