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Sr. Regulatory Professional Companion Diagnostics

Organization

Agilent

Job Location

1005 Mark Avenue
Carpinteria, CA 93013
United States

Job Description

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.

Be part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to laboratories, partners and patients globally. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.

 

In the Companion Diagnostics Business (CDx), our team partners with leading pharmaceutical companies to develop, manufacture and commercialize highly regulated medical devices which are critical for phycisions to help select therapies for their patients.

 

Companion Diagnostics (CDx) Regulatory Affairs ensures compliance to medical device and CDx IVD regulations globally. In conjunction with Enterprise Global Regulatory Affairs, the CDx Regulatory Affairs Department communicates with worldwide health authorities in the licensing of all products in development or currently marketed globally. The Regulatory Professional integrates broad business concepts and strategies into structured projects leading design and delivery of new products and solutions as a ket technical contributor. Ability to solve complex, high impact project design problem is required.

 

Main Responsibilities

  • Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
  • Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
  • Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
  • Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
  • Reviews product labeling and marketing materials for accuracy and compliance with regulations.
  • Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
  • Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
  • May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
  • Determines and develops approaches to assignments
  • Leads regulatory projects requiring coordination with other functions, third parties
  • Solves a broad range of problems of varying scope and complexity

Requirements

  • Bachelors or Masters Degree or University Degree or equivalent in a relevant field.
  • 4+ years relevant experience for entry to this level.
  • Requires in-depth knowledge and experience in job and ability to work independently.