AbbVie · 3 days ago
Senior Manager, Regulatory Affairs Device (Hybrid)
Irvine, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$121K/yr - $230K/yr
8+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The Senior Manager, Regulatory Affairs, Device will work with internal and external partners to prepare regulatory strategies and manage submissions, ensuring compliance and successful product delivery.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Prepares device regulatory product strategies
Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations, and responds to regulatory information
Analyzes and interprets information that impacts regulatory decisions
Seeks expert advice and technical support as required for strategies and submissions
Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
Responds to global regulatory information requests
Develops strategies for device agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions
Manages products and change control with an understanding of regulations and company policies and procedures
Analyzes and approves manufacturing change requests
Represents RA Device on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
Stays abreast of regulatory procedures and changes in regulatory climate
Analyzes legislation, regulation and guidance, provides analysis to the organization
Develops, implements, and documents policies and procedures within the regulatory affairs department
Participates in initiatives internal to RA Device
Qualification
Required
Bachelor's Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject
8 years pharmaceutical experience
Knowledge of the ISO/CE process and global product registration process
Experience with eCTD tools and EDMS applications
Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products
Understanding of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR. 236:2002, ANVISA RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan's devices and combination products
Experience developing and implementing successful global regulatory strategies and working in a complex and matrix environment
Strong oral and written communication skills
Preferred
Relevant advanced degree preferred
Certification a plus
10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie 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 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-07
2026-01-06
2026-01-06
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