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Bio Regulatory Engineer

Organization
Agilent
Job Location
2850 Centerville Rd
Wilmington, DE 19808
United States
Job Description

Job Description

Agilent inspires 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. Information about Agilent is available at www.agilent.com.

Agilent's portfolio of biological products continues to expand through recent acquisitions as well as innovation. To meet the growing demand of biological regulatory expertise, we are expanding our regulatory function and adding a new and exciting role to our team. We are looking for a biological regulatory affairs professional, who is looking for a new challenge. You will play a key role in enabling our products to be sold to customers worldwide that can benefit from Agilent solutions.

  • Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global biological regulations
  • Determine compliance of Agilent Biological products for global sale, licensing requirements, and customs declarations
  • Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements
  • Documents regulatory processes to ensure alignment with Quality and Regulatory standards
  • Maintain and track compliance metrics and product documentation
  • As needed, collaborate with business Project Teams and ACG regulatory staff to ensure all biological regulatory requirements are identified and implemented

 

Requirements

Qualifications

  • Bachelors Degree or University Degree
  • 8+ years experience within Product Biological Regulatory Affairs, Quality Engineering, product stewardship or other regulatory- based field
  • Demonstrated teamwork sills and ability to collaborate and work effectively in teams across different businesses, functions, and geographies
  • Clear communication skills, data management, problem-solving skills, and ability to multi-task
  • Proficient with Microsoft Excel and SAP

Preferred Qualifications:

  • Biochemistry Degree
  • Global trade experience

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