Regulatory Affairs Expert

Agilent Technologies•Paradise, NV

10d•$124,160 - $232,800•Remote

About The Position

We are looking for a highly skilled regulatory professional for a Regulatory Affairs Expert role within the Diagnostic Regulatory Affairs team. This is a brilliant and collaborative team of professionals that face exciting challenges and opportunities. This person will act independently to apply advanced approaches and concepts to solve complex, high-impact regulatory matters. Your Responsibilities Will Include: 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. Leads regulatory projects requiring coordination with other functions, third parties. Solves a broad range of problems of varying scope and complexity.

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.
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.
Leads regulatory projects requiring coordination with other functions, third parties.
Solves a broad range of problems of varying scope and complexity.