Sr. Regulatory Professional

Agilent Technologies•Clovis, CA

8d•Remote

About The Position

This is an exciting opportunity to 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 physicians to help select therapies for their patients. As the Regulatory Companion Diagnostics Professional, you will ensure compliance to medical device and CDx IVD regulations globally. In conjunction with other groups in 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 key technical contributor. The ability to tackle complex, high-impact project design problems is required.

Requirements

Bachelor’s or Master’s Degree or equivalent
8+ years relevant experience for entry to this level.
Possess proven experience in a similar role.
Requires in-depth knowledge and experience in the job and the ability to work independently.

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.
Response to customers and/or authorities' requests/inquiries dealing with regulations and product compliance.
Represents the company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
May assess requirements and identify strategies for the 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.