Sr. Regulatory Professional jobs in United States
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Agilent Technologies · 1 day ago

Sr. Regulatory Professional

Agilent Technologies is focused on improving the human condition through precision medicine. The Regulatory Companion Diagnostics Professional will ensure compliance with medical device regulations globally and lead regulatory projects while collaborating with various teams to facilitate product approvals.

BiotechnologyHealth CareHealth DiagnosticsLife SciencePharmaceutical
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Culture & Values
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H1B Sponsor Likelynote

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

Qualification

Regulatory complianceMedical device regulationsRegulatory submissionsRisk managementProject managementCommunication skillsProblem-solvingTeam collaboration

Required

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

Benefits

Bonus
Stock
Benefits

Company

Agilent Technologies

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Agilent Technologies addresses the scientific and laboratory management needs of analytical scientists and clinical researchers.

H1B Sponsorship

Agilent Technologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (51)
2024 (56)
2023 (58)
2022 (70)
2021 (64)
2020 (53)

Funding

Current Stage
Public Company
Total Funding
$500M
2019-09-05Post Ipo Debt· $500M
1999-11-26IPO

Leadership Team

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Mike McMullen
CEO and President
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Padraig McDonnell
President and CEO
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Company data provided by crunchbase