Sr. Regulatory Affairs Specialist

Company: Agilent Technologies, Inc.
Location: Santa Clara
Posted on: May 11, 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.
  
  • Bachelors, Masters or University Degree or equivalent in Engineering or Scientific/Technical discipline preferred; may consider other education and/ or combination of education and experience.
  • Typically 8+ years relevant experience for entry to this level.
  • Knowledge of medical device/IVD regulations as defined by FDA, EU IVDR, ISO 13485, and other applicable standards experience with writing and submitting regulatory submissions (FDA, EU, ROW).
  • Strong written and verbal communication skills, especially having the ability to explain and resolve differences in interpretation of standards, regulations, and regulatory/compliance requirements.
  • Effectively interact with, and understand, the different stakeholders within a global, multi-business organization.Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-289-290-3856 or email janet_fiore@agilent.com

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