Job 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 our website.
We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team. 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.
Responsibilities:
* Prepare document packages for regulatory submissions and listings to ensure compliance with local and regional 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 products are safe, legal, and compliant with regulations.
* Identify and escalate regulatory and compliance issues to senior management.
* Monitor regulatory changes and participate in discussions related to regulation updates, assessing and communicating potential impacts.
* Lead regulatory projects involving coordination with Legal, Marketing, Project Management, and distributors.
* Support regulatory impact assessments for change controls.
* Coordinate the preparation of documentation for permits, licenses, and registrations.
* Consult with regulatory agencies for guidance and interpretation of regulations.
* Communicate with Channel Partners regarding registrations and change assessments.
Location:
This position is preferably based in our Waldbronn office in Germany (hybrid model), but can also be based 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.
* Knowledge of international registrations.
* Strong teamwork skills and ability to collaborate across functions and geographies.
* Experience with Quality Management Systems (QMS) in the medical device industry.
* Proficiency in English.
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 understanding of ISO quality standards and IVD regulations.
We Offer:
* Global benefits, yearly bonus, private healthcare, pension, stock purchase plan, insurance, and more.
* Opportunities for growth within a global, innovative company.
* Diverse and inclusive work environment.
* Collaborative, agile culture promoting work-life balance.
* Permanent contract in a fast-growing organization.
We look forward to receiving your application in English. For more about us, visit our awards page: Awards | Agilent Technologies.
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