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.

We seek someone of high caliber talent who has established themselves as an expert in Complaint Handling and reporting to FDA and other regulatory authorities in the area of medical devices/IVDs. This role will be hands-on and will also have an opportunity to manage employees involved in the investigation, processing, and closing of complaints as well as facilitating MDR and vigilance reporting, providing input to metrics, and ensuring timelines for reporting are met for products manufactured by Agilent.

You will work closely with Agilent's Quality and Regulatory teams as well as the Field Service Engineers, Product Support, Research & Development, and manufacturing organizations to ensure complaints are thoroughly investigated.

Specifically, you will:

• Develop, manage, and maintain a product-specific complaint investigation team including the hiring, training, and compliance.
• Participate in the development and maintenance, in collaboration with product subject matter experts and medical affairs, product failure modes for consistent reporting, trending, and identified user and patient safety decisions.
• Ensure complaints are investigated, addressed, and closed in a globally compliant manner which includes, when needed, the coordination of manufacturing and/or R&D complaint investigations with businesses.
• Ensure complaints are assessed for global reportability and MDRs, Vigilance and similar reports are submitted to Regulatory Authorities on time.
• Coordinate and provide input into trends and metrics ensuring management is aware of any negative trends. Support the business, as requested, when improvements are needed to correct negative trends.
• Escalate complaint issues as they arise. Support businesses when potential field actions and/or recalls are identified.
• Other tasks as assigned to support the business goals and objectives