Associate Specialist, Labeling

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives.

The Associate Labeling Specialist will work with the cross-functional project team to deliver best labeling solutions, drive label and IFU release, and support the implementation of various projects.

Key Responsibilities:

• Determine labeling requirements for routine labeling change packages (e.g., MDRs, sustaining changes label/IFU content, CMS migration) by translating business needs for existing labeling documentation (e.g., IFU, product labeling, operations manual) and prioritizing execution workflow. Partner with team members to ensure label change package execution meets project deliverables.
• Collaborate with business unit stakeholders in the development of solutions for labeling projects.
• Follow and maintain timetables for creating new/revised content and labeling in a cost-effective manner
• Evaluate routine risks and provide recommendations to resolve issues.
• Participate in process improvement projects
• Other incidental duties: Participate in risk assessments to support NCR and CAPA activities

Minimum Qualifications:

• Bachelor's Degree with 1 year of related experience Required

Preferred Qualifications

• Previous experience working in a medical/ pharmaceutical FDA regulated industry
• Good computer skills including usage of MS Office Suite
• Excellent written and verbal communication skills and interpersonal relationship skills
• Ability to follow established grammatical and formatting conventions, templates and style guides
• Able to read, comprehend, write, and speak English
• Moderate understanding of domestic development and implementation of labeling
• Basic understanding of medical and/or pharmaceutical regulations and standards
• Basic knowledge of medical device documentation development activities
• Knowledge of ECR and Ignite processes
• Good computer skills including usage of MS Office Suite
• Basic problem-solving, organizational, analytical and critical thinking skills
• Strict attention to detail
• Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
• Participates in arranging own activities in accomplishing objectives
• Ability to evaluate change package and make decisions on resource consumption
• Contributes to the completion of sections of organizational projects and goals Errors in judgment or failure to achieve results may require some expenditures of resources to rectify
• Ability to build stable working relationships internally
• Develops solutions to a variety of problems of basic scope and complexity
• Participate in process improvements

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $53,000 to $75,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice