Associate Specialist, Labeling Jobs

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.
• Participate in process improvement projects
• Other incidental duties: Participate in risk assessments to support NCR and CAPA activities
• 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.
• Collaborate with business unit stakeholders in the development of solutions for labeling projects.

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

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

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).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.