Sr. Regulatory Affairs Specialist

Company: Agilent
Location: Santa Clara
Posted on: May 15, 2022

Job Description:

To protect the health and safety of our employees, contractors, customers and communities, employees in the U.S. and Puerto Rico are required to be fully vaccinated against COVID-19, unless an approved exemption has been granted for a medical reason, sincerely held religious belief, or an employee is otherwise exempt under applicable law.
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 Global Regulatory Affairs Team is seeking a Regulatory Affairs Specialist with a strong In Vitro Diagnostics (IVD) background to support global Life Science and Applied Markets Group product teams with new product introduction, registrations and other regulatory deliverables. You will be part of a smart, driven team that shares your passion for ensuring the highest quality in the medical device field.As a regulatory affairs specialist, you will help develop and implement programs to ensure the company's products are safe, legal, and comply with national, regional, and global regulations. The primary focus for this role will be leading projects focused on helping LSAG product lines comply with the In Vitro Diagnostic Regulation (IVDR) for products to be marketed in the European Union (EU). You will also work closely with other RA teams, Clinical Affairs, and other stakeholders to provide regulatory guidance on projects and key activities to assist the business in achieving its strategic goals.
Essential Responsibilities:

• Lead LSAG IVDR initiatives in multiple product lines.
• Provide guidance on creating and updating technical files.
• Compile required documents for any necessary regulatory submissions, annual registrations, and license renewals.
• Prepare document packages for regulatory submissions for FDA, EU (IVDR), and ROW.
• Participate on project teams to ensure compliance to national, regional, or global regulatory requirements for EU, China, US and other international markets as needed.
• Assist in the development of regulatory strategies for LSAG products/projects
• Manage improvement projects for the LSAG RA team and across businesses.
• Provide regulatory support & input to the business teams on product development processes, such as design control (risk management, design review, PLC consultancy), change management of released products (DHF/DMR management, RA review for ECO/ECR).
• Assist with inspections, audits, and/or other agency interactions with FDA or other regulatory bodies.
• Interact closely with enterprise QA/RA to identify relevant standards and guidance documents that affect LSAG's business and products.
• Review and approve product and package labels as well as marketing/promotional labeling material.

Keywords: Agilent, Santa Clara , Sr. Regulatory Affairs Specialist, Other , Santa Clara, California