Associate Specialist, Labeling

1 week ago

Irvine, United States Edwards Lifesciences Corp Full time

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease. For more than 60 years, we have established a remarkable track record around innovation and quality: Work that enables clinicians around the world to enhance and save lives.

The Associate Labeling Specialist role partners with business cross-functional project teams to deliver labeling solutions, drive label and IFU creation and release, and support the implementation.

How you will make an impact:

* Determine labeling requirements for routine, sustaining labeling change packages (e.g., US FDA, EU MDR, and country specific label/IFU content, CMS migration) by translating business needs for existing labeling documentation (e.g., IFU, product labeling, operations manual) to functional design
* 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
* Prioritize workflow, 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

What you'll need (Required):

* Bachelor's Degree with 1 year of related experience

What else we look for (Preferred):

* Previous experience working in a medical/pharmaceutical FDA regulated industry
* Good computer skills including usage of MS Office Suite, design software experience is a plus
* Excellent written and verbal communication skills and interpersonal relationship skills
* Able to build stable working relationships internally
* Able to read, comprehend, write, and speak English
* Ability to follow established grammatical and formatting conventions, style guides, design templates
* Basic understanding of principles of content management is a plus
* Understanding of medical device design elements, experience with translations workflow is a plus
* 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 Change Control processes
* 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
* 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 $56,000 to $80,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.

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

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.

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