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Senior Regulatory Specialist (m/f/d) - IVD, Ireland
Client: Agilent
Location: Ireland, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 8e5ba0989419
Job Views: 1
Posted: 02.05.2025
Expiry Date: 16.06.2025
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's IVD portfolio.
The role ensures products are received, licensed, and delivered in compliance with global regulatory and quality standards. 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 requirements.
* Compiling materials for submissions, license renewals, and annual registrations; maintaining export licenses within SAP for IVD licenses and managing global trade holds.
* Developing and implementing programs to ensure product safety, legality, and compliance with regulations.
* Raising regulatory and compliance issues to senior management.
* Monitoring regulatory changes and participating in discussions to assess and communicate potential impacts.
* Leading regulatory projects involving coordination with Legal, Marketing, Project Management, and distributors.
* Supporting regulatory impact assessments for change controls.
* Coordinating the preparation of documentation for permits, licenses, and registrations.
* Consulting with regulatory agencies for guidance and interpretation.
* Communicating with Channel Partners regarding registrations and change assessments.
This position is preferably based in our Waldbronn office in Germany (hybrid model), but can also 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, leadership, and collaboration skills across functions and geographies.
* Experience with Quality Management Systems (QMS) for medical devices.
* Proficiency in English, both written and spoken.
Preferred Qualifications
* Excellent communication, project management, and presentation skills.
* Knowledge of design controls and standards such as ISO 13485 and 14791.
* Experience with regulated products, ISO quality standards, and IVD regulations.
We offer:
* Global benefits, yearly bonus, private healthcare, pension, stock purchase plan, and insurance (varies by country).
* Opportunities for professional growth within a global company.
* Inclusive and diverse workplace culture.
* Autonomous role in a supportive environment emphasizing integrity and trust.
* Exciting projects within a dynamic, agile team.
* Encouragement of work-life balance.
* Permanent contract in a growing global organization.
We look forward to receiving your application in English. Agilent is recognized as one of the best employers worldwide: Awards | Agilent Technologies
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