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Regulatory Affairs Manager -MD/IVD

Job Description


Our mission is to help our customers around the world to fight cancer and other life-threatening diseases. We are driven to provide the best solutions, to ensure accurate and early diagnosis, to improve treatment, and enhance survival rates and quality of life.

We are seeking a Regulatory Affairs Manager for a team that will play an important role in managing the submissions, approvals and maintenance of Agilent products in conjunction with responsible business associates. You will ensure products are in alignment and in compliance with national, regional and global regulations, company policies and business objectives.

As an established professional you will apply leadership skills to oversee supervisors, employees and resources involved in the design of quality processes, you will advise the implementation of tactical business plans, programs and projects, while also delivering solutions that drive continuous process improvement to ensure quality products are designed, engineered and manufactured by Agilent.

  • Develop and implement programs and processes to ensure that our products are safe, legal, and meet or exceed customer expectations for regulatory compliance.
  • Oversee and direct quality and/or regulatory activities, and executes key strategic programs within assigned area of responsibility.
  • Represents the company in industry associations and standards bodies and may interact with regulatory agencies.
  • Handle development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
  • Supervise audits of production and quality control areas and raw material vendors. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
  • About Us

    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.



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