Regulatory Affairs Expert

Job Description

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.

Qualifications

• 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.

#LI-PK1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 13, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $124,160.00 - $232,800.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds 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 creating and maintaining an inclusive in the workplace where everyone is welcome, 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 email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory Apply tot his job Apply To this Job