Edwards Lifesciences ยท 5 hours ago
Analyst, Clinical Device Management
Irvine, CA
Full-time
Hybrid
Mid Level
$72K/yr - $98K/yr
3+ years expEdwards Lifesciences is a company focused on generating clinical evidence to enhance patient outcomes. As a Clinical Device Management Analyst, you will develop and optimize device management processes for clinical trials, ensuring compliance with regulatory requirements and overseeing the lifecycle of clinical devices.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Analyze clinical device data and notify cross functional team members (e.g., CRA, CS, and/or site coordinator) for data updates/changes
Partner with Quality to resolve device related issues
Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.)
Develop training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff
Provide training on device accountability process within electronic database (e.g., SalesForce) for cross functional team members (e.g., clinical specialist and field monitors)
Compile and analyze accurate date of regulatory reports for submission for the regulatory bodies (e.g., FDA)
Identify technical and data issues and collaborate with appropriate team members to bring to resolution
Assist in the determination of root cause and recommend and implement corrective actions
Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., transition to new device system, system enhancements, etc.) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines
Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables
Other incidental duties
Qualification
Required
Bachelor's Degree in related field with 3 of previous clinical trial management experience, or equivalent work experience based on Edwards criteria
Preferred
Experience with iOS Apple products, including proficiency in using applications on iPad
Experience managing clinical trials within medical device industry
Understanding and knowledge of clinical device accountability
Proven expertise in Microsoft Office Suite, including Excel, JDE, electronic database (e.g., Salesforce) required
Good written and verbal communication skills and interpersonal relationship skills
Demonstrated problem-solving and critical thinking skills
Moderate understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management
Moderate understanding and knowledge of clinical device accountability
Moderate problem-solving, organizational, analytical and critical thinking skills
Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents
Moderate knowledge in Microsoft Office Suite, including Excel, JDE, electronic database (e.g., Salesforce) required
Good written and verbal communications skills
Moderate problem-solving skills
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
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