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Senior Regulatory Specialist (m/f/d) - IVD, Church Stretton
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Client:
Agilent
Location:
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
46f6dcc71543
Job Views:
4
Posted:
02.05.2025
Expiry Date:
16.06.2025
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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 will 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 accordance with global regulatory and quality standards. As a member of the Global Regulatory Team, you will:
* Prepare document packages for regulatory submissions and listings, ensuring compliance with local and regional registration requirements and company policies.
* Compile materials required for submissions, license renewal, and annual registrations. Maintain export licenses within SAP for IVD licenses and address global trade holds.
* Develop and implement programs and processes to ensure product safety, legality, and compliance with regulations.
* Identify and escalate regulatory and compliance issues to senior management as needed.
* Monitor regulatory changes and participate in discussions related to regulation updates, communicating potential risks and opportunities.
* Lead regulatory projects, coordinating with Legal, Marketing, Project Management, and distributors.
* Support impact assessments for change controls on registered products.
* Coordinate the preparation of documentation for permits, licenses, and registrations.
* Consult with regulatory agencies for guidance on regulations.
* Communicate with Channel Partners regarding registrations and change assessments.
This position is preferably based in our Waldbronn office in Germany (hybrid), but can also be located anywhere in Europe where Agilent has an entity.
Qualifications
* Bachelor’s degree in Regulatory Affairs, Quality Assurance, Engineering, or a related science field
* Several years of relevant experience in regulated environments
* Experience with international registrations
* Strong teamwork skills and ability to lead and collaborate across functions and geographies
* Experience with Quality Management Systems (QMS) for medical devices
* Proficient in English, both written and spoken
Preferred Qualifications
* Excellent communication, project management, and presentation skills
* Knowledge of design controls and standards like ISO 13485 and 14791
* Experience with regulated products and knowledge of ISO standards and IVD regulations
We offer:
* Comprehensive global benefits, including bonuses, private healthcare, pension, stock plans, and insurance (varies by country)
* Opportunities for growth and career development in an international setting
* Inclusive culture and diverse perspectives
* Autonomous work environment with supportive colleagues
* Exciting projects within a dynamic, agile team
* Work-Life Balance initiatives
* Permanent contract in a growing global company
We look forward to your application in English.
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