Associate Specialist, Labeling

14 hours ago

Irvine, United States Edwards Lifesciences 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.

  • Associate Specialist, Labeling

    15 hours 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...

  • Labeling Specialist

    6 days ago

    Irvine, United States Hydrogen Group Full time

    Labeling Design Specialist - Medical Devices Location - Hybrid (Irvine, CA)Duration - Initial 12 Month Contract (potential for extension)Pay Rate - $45-50/hour. Responsibilities:Responsible for ensuring that all tasks related to updates or changes in global labeling standards and procedures, training plans, process enhancements, and the routing and approval...

  • Labeling Specialist

    6 days ago

    Irvine, United States Hydrogen Group Full time

    Labeling Design Specialist - Medical Devices Location - Hybrid (Irvine, CA)Duration - Initial 12 Month Contract (potential for extension)Pay Rate - $45-50/hour. Responsibilities:Responsible for ensuring that all tasks related to updates or changes in global labeling standards and procedures, training plans, process enhancements, and the routing and approval...

  • Labeling Designer

    2 months ago

    Irvine, United States Entegee Full time

    Job DescriptionJob DescriptionJob Summary: Label Design Specialist responsible for developing and testing label designs, applying GS-1 compliant barcodes, and working within a regulated medical device or pharma environment.Requirements:Experience developing and testing label designs from templates using Codesoft and SQL databasesWorking level understanding...

  • Sr Labeling Specialist CA

    1 week ago

    Irvine, United States Talentburst Full time

    Position: Sr Labeling Specialist, Req#: 9059-1Is this the role you are looking for If so read on for more details, and make sure to apply today. Location: Irvine, CA (Mostly from home, but the first couple of weeks onsite for training in the Irvine, CA office). Duration: 12+ Months Contract (with the high possibility of extension.) More on this role: What...

  • Sr Labeling Specialist CA

    2 weeks ago

    irvine, United States TalentBurst Full time

    Position: Sr Labeling Specialist, Req#: 9059-1 Location: Irvine, CA (Mostly from home, but the first couple of weeks onsite for training in the Irvine, CA office). Duration: 12+ Months Contract (with the high possibility of extension.) More on this role: What does your group do? We design and release labels, IFUs and other labeling components supporting APM...

  • Label Manager

    1 week ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Sr Labeling Specialist, Req#: 9059-1Location: Irvine, CA (Mostly from home, but the first couple of weeks onsite for training in the Irvine, CA office). Duration: 12+ Months Contract (with the high possibility of extension.)More on this role:What does your group do?We design and release labels, IFUs and other labeling components supporting APM...

  • Label Manager

    1 week ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Sr Labeling Specialist, Req#: 9059-1Location: Irvine, CA (Mostly from home, but the first couple of weeks onsite for training in the Irvine, CA office). Duration: 12+ Months Contract (with the high possibility of extension.)More on this role:What does your group do?We design and release labels, IFUs and other labeling components supporting APM...

  • Labeling Design Specialist

    1 week ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Title: Labeling Design RepresentativeLocation: Irvine, CA 92618Duration: 12 months Job Description: Role PurposeProcess pre-designed changes by using labeling software.Job FunctionsEssential Job Functions% of TimeExecute complex designed labeling changes (e.g., illustrations), using SDL and Loftware solutions. 65%Evaluate risks, provide recommendations to...

  • Labeling Design Specialist

    1 week ago

    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Title: Labeling Design RepresentativeLocation: Irvine, CA 92618Duration: 12 months Job Description: Role PurposeProcess pre-designed changes by using labeling software.Job FunctionsEssential Job Functions% of TimeExecute complex designed labeling changes (e.g., illustrations), using SDL and Loftware solutions. 65%Evaluate risks, provide recommendations to...

  • Senior Rep, Labeling

    10 hours ago

    Irvine, United States Edwards Lifesciences Full time

    Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. The Sr....

  • Sr Labeling Specialist CA

    1 week ago

    Irvine, CA, United States TalentBurst Full time

    Position: Sr Labeling Specialist, Req#: 9059-1 Location: Irvine, CA (Mostly from home, but the first couple of weeks onsite for training in the Irvine, CA office). Duration: 12+ Months Contract (with the high possibility of extension.) More on this role: What does your group do? We design and release labels, IFUs and other labeling components supporting APM...

  • Light Industrial

    1 week ago

    Irvine, United States Talentburst Full time

    Title: Labeling Design RepresentativeScroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect. Location: Irvine, CA 92618 Duration: 12 months Job Description: Role Purpose Process pre-designed changes by using labeling software. What does this group do? We design and release labels, IFUs and other...

  • Light Industrial

    2 days ago

    Irvine, United States Talentburst Full time

    Title: Labeling Design RepresentativeIs this the next step in your career Find out if you are the right candidate by reading through the complete overview below. Location: Irvine, CA 92618 Duration: 12 months Job Description: Role Purpose Process pre-designed changes by using labeling software. What does this group do? We design and release labels, IFUs...

  • Light Industrial

    2 days ago

    Irvine, United States Talentburst Full time

    Title: Labeling Design RepresentativeIs this the next step in your career Find out if you are the right candidate by reading through the complete overview below. Location: Irvine, CA 92618 Duration: 12 months Job Description: Role Purpose Process pre-designed changes by using labeling software. What does this group do? We design and release labels, IFUs...

  • Light Industrial

    2 weeks ago

    irvine, United States TalentBurst Full time

    Title: Labeling Design Representative Location: Irvine, CA 92618 Duration: 12 months Job Description: Role Purpose Process pre-designed changes by using labeling software. What does this group do? We design and release labels, IFUs and other labeling components supporting APM sustaining and new product development projects. Does the team use any specific...

  • Regulatory Affairs Specialist II

    3 weeks ago

    Irvine, California, United States Yoh, A Day & Zimmermann Company Full time

    Job OverviewYoh, A Day & Zimmermann Company, is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a Regulatory Affairs Specialist II, you will be responsible for supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities, preparing revision of technical files, updating labeling to comply with IVDR...

  • Regulatory Affairs Specialist

    3 months ago

    Irvine, United States Tucker Parker Smith Group (TPS Group) Full time

    Regulatory Affairs Specialist II Location: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE...

  • Regulatory Affairs Specialist

    3 weeks ago

    Irvine, United States Tucker Parker Smith Group (TPS Group) Full time

    Regulatory Affairs Specialist II Location: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE...

  • Regulatory Affairs Specialist II

    3 weeks ago

    Irvine, United States Tucker Parker Smith Group (TPS Group) Full time

    Job DescriptionJob DescriptionRegulatory Affairs Specialist II Location: Irvine, CA (Hybrid 3 days on site)12 month Assignment (Potential to extend or convert)Pay Rate: $45-$49/hr. On behalf of our client a Medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition...