Edwards Lifesciences ยท 6 hours ago
Senior Analyst, Project Management, Regulatory Affairs Surgical
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $127K/yr
5+ years expEdwards Lifesciences is dedicated to innovation in cardiac surgery, aiming to improve patients' quality of life. The Senior Analyst will lead project management tasks, manage project risks, and ensure regulatory compliance for mid-to-large scale projects in the Surgical business unit.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Lead the execution of tasks as defined in the project management plan and actively manage project risk
Determine and discern detailed requirements on mid-to-large scale projects to establish the project deliverables and develop the project management plan, and manage changes to the project scope, schedule, and costs to keep the project management plan updated and reflective of authorized project changes
Determine and discern detailed requirements on submissions deliverables, schedule and tracking of appendices and documents for mid-to-large regulatory affairs projects
Lead various regulatory affairs improvement initiatives, including submission standardization, regulatory systems, and standards management
Develop procedures, checklists, templates supporting submission quality and best practices
Prepare for and provide guidance on regulatory agency inspections and audits (e.g., track ra plans and changes, understanding requirements)
Assess project performance to monitor the progress of the project, identify and quantify variances, perform required corrective actions and communicate to all stakeholders
Establish and coordinate team members and stakeholder relationships, expectations, and communications
Qualification
Required
Bachelor's Degree & a minimum of 5 years experience hands on experience managing mid-to-large scale projects OR equivalent based on Edwards criteria
Preferred
Project Management Professional (PMP)
Certified Notary Public with active license, authorized to verify and authenticate legal documents, contracts, and signatures to ensure compliance and accuracy
Regulatory Affairs project management experience
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Substantial understanding and knowledge of principles, theories, and concepts relevant to managing small-to-mid-scale project plans
Ability to adapt to rapidly changing environment
Strong problem-solving, organizational, analytical and critical thinking skills
Benefits
Competitive salaries
Performance-based incentives
Wide variety of benefits programs
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
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 (69)
2024 (72)
2023 (43)
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
BioWorld Financial Watch
2025-12-25
Medical Device Network
2025-12-25
Company data provided by crunchbase