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Job Details

Labelling Specialist

Type

Full time

Location
Ireland-Limerick
Job reference

Req-35640

Posted for

5 months ago

Job Description
Evaluate content to establish standardised labels across product lines and families. Analyse and implement a consistent approach to template and labelling design/execution in a component content management platform.

How Will You Make An Impact?
  • Create and execute solutions; includes content and format analysis of existing for label designs.
  • Evaluate risk assessment and proposed solutions based on redlines. Identify issues and risks associated with proposed design. Apply technical expertise and perspective to simplify proposed labeling designs. Identify, define and implement process improvements to enhance solutions.
  • Collaborate with Labelling Specialist and change initiator to refine solution requirements, provide innovation and cost-effective design solutions in a timely manner.
  • Develop standard label templates and labelling content with the Global Labelling Systems.
  • Create and updates to related Global Labelling Standards, Procedures, Step guides, and Training materials.
  • Other incidental duties: working with different suppliers and vendors to propose improvement opportunities, organising label stocks inventory within global labeling team and with suppliers. Provide training and coaching to new labeling designers

What You Will Need?
  • Bachelor's Degree in a related field
  • Related experience in Labeling Required

Additional Skills:
  • Experience working in a regulated industry preferred
  • Proven successful project management leadership skills
  • Proven expertise in Microsoft Office Suite and related tools and systems
  • Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Ability to listen to the customer’s requirements, desires and concerns, and then determining whether to recommend standardised/harmonised solutions or possibly customizing a path forward, given a variety of problems of moderate scope and complexity.
  • Ability to build productive relationships, influence others and deliver effectively in ambiguous situations
  • Good leadership skills
  • Experience managing tasks of projects
  • Moderate understanding of domestic and global development and implementation of labeling
  • Moderate understanding of medical and/or pharmaceutical regulations and standards
  • Moderate knowledge of Edwards standards and FDA regulations in relations to labeling and documentation
  • Moderate knowledge of medical device documentation development activities
  • Knowledge of ECR and PDM processes
  • Strict attention to detail
  • Ability to build productive internal/external working relationships
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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Job reference

Req-35640

Apply Now
Type

Full time

Location
Ireland-Limerick
Posted for

5 months ago

SHARE THIS JOB
Apply Now
About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

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What we offer

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Important Notices for Candidates

Important Notices for Candidates

COVID Vaccination Requirement Notice

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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