Edwards Lifesciences · 1 day ago
Manager, Labeling
USA - California – Irvine
Full-time
Onsite
Mid, Senior Level
$118K/yr - $167K/yrEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Manager, Labeling position involves leading labeling operations activities, managing a small team, and collaborating with stakeholders to deliver effective labeling solutions while ensuring compliance with policies and procedures.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Lead and manage demand for labeling operations activities, through collecting requirements, determining high level scope, justification, and rationale from concept through label release, including initiating and delivering to Operations labeling content and design changes
Assess business needs (e.g., portfolio specific labeling changes for BU product line), determine requirements, and provide labeling solutions in collaboration with BU stakeholders while establishing personal rapport and building sustainable relationships of trust through open and collaborative communications
Manage a small team within Labeling
Deliver labeling solutions per policies and procedures
Plan and direct assigned operational and/or project activities with the accountability for successful completion of assigned deliverables per priority mechanism
Drive labeling design and solution activities for product labels, instructions for use (IFU) and other forms of regulated labeling materials
Educate, train, and guide stakeholders to provide accurate information in support of successful labeling changes and new label development
Sustain production flow by monitoring process, providing input and reporting on performance metrics
Resolve design operations problems by analyzing data, investigating issues; identifying, recommending and leading the implementation of solutions
Develop team members to increase business acumen and functional skills
Initiate root cause investigations for labeling operations driven non-conformances and CAPA investigations and ownership
Develop labeling operations metrics and lead the execution of operations quality initiatives
Drive less complex standardized solution development and best practices for labeling initiatives, including recommending and partnering with team members on activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations
Evaluate risks and execute cost-effective labeling approaches to resolve critical issues
Optimize labeling standards within assigned BU
Develop report on demand and forecast labeling changes for assigned BU
Other incidental duties
Qualification
Required
Bachelor's Degree in a related field and experience in Labeling OR equivalent work experience based on Edwards criteria
Preferred
Master's Degree or equivalent in a related field and experience working in a regulated industry
Proven successful project management leadership skills
Proven expertise in Microsoft Office Suite and related tools and systems
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Extensive understanding of Labeling procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
Knowledge of financial mechanism that relates to Labeling
Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value to the business
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Adherence to quality system, global and regional Labeling standards and regulations
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Primarily interacts with internal subordinates and other supervisors
Typically interacts with external suppliers, vendors and/or customers
Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
Dedicated to quality client service and pro-active and responsive to client needs
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
Founded in 1958
10001+ employees
H1B Sponsorship
Edwards Lifesciences 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 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
Orange County Business Journal
2026-01-14
2026-01-13
Medical Device Network
2026-01-13
Company data provided by crunchbase