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.
The successful candidate will join a growing Global Regulatory Affairs Group.
-Manages the submission, approval and maintenance of Agilent products into the Americas region (North America, South America and Central America) in conjunction with responsible business associates and ensures products are in alignment and compliance with national, regional and global regulations, company policies and business objectives.
-Develops and implements programs and processes to ensure that Agilent products are safe, legal, and meet or exceed customer expectations for regulatory compliance. Oversees and directs quality and/or regulatory activities, and executes key strategic programs within assigned area of responsibility.
-Provides labeling reviews to business and approves marketing materials.
-Reviews regulatory qualifications of distributors in conjunction with other business partners to ensure all regulatory requirements are met and maintained.
-Selects, develops and evaluates personnel to ensure the efficient operation of the function.
-Acts as a change agent to help establish regulatory compliance.
-Ensures quality management system procedures are accurate and current. Provides expertise in translating regulatory requirements into practical, workable plans.
-Supports the development and implementation of global strategies for timely submission and approval of product regulations and supporting business related product submissions in the regions.
-May represent the company in industry associations and standards bodies and will interact with regulatory agencies.
-May manage development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
-May support regional audits of suppliers, and/or service providers.
-May support FDA inspections.
-Manages supervisors and manages enterprise regulatory associates located in the Americas region
-Supports the management of distributor relationships in the regions
-Develops, implements solutions to department and enterprise global issues and regulations