Description
For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who should be monitored will be monitored with smart technology.
If you're eager to contribute your expertise and commitment to Critical Care's mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.
On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards' announcement about the acquisition can be found here:
The Sr. Specialist, Labeling Design will evaluate content to establish standardized labels across product lines and families. Analyze and implement a consistent approach to template and labeling design/execution in a component content management platform.
**You'll make an impact by:**
- Create and lead the execution of solutions; including content and format analysis of existing for label designs.
- Evaluate risk assessment and provide alternative solution identification, risk assessment and implement proposed solutions. Identify issues and risks associated with proposed design
- Lead, coordinate and perform as technical Subject Matter Expert for complex labeling projects and activities thru rigorous process identification and solution definition.
- Collaborate with Labeling Specialist and change initiator to refine solution requirements, provide innovation and cost-effective design solutions in a timely manner.
- Lead labeling design, development and process standardization and harmonization using Global Labeling systems.
- Develop, revise and implement labeling procedures and training requirements and coach other labeling designers.
- Other incidental duties: Lead and manage NCR and CAPA activities as it relates to labeling design. Collaborate with the cross functional team to address challenges related to printing labeling components. Manage illustration artwork in different systems (e. g., Mac server, CMS).
**What you'll need:**
- Bachelor's Degree in related field and 5 years of experience in Labeling.
**What else we look for:**
- Master's Degree or equivalent and 3 years of experience in Labeling.
- Experience working in a regulated industry.
- Demonstrated track record in people management.
- 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 standardized/harmonized 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.
- Proven success adhering to and leading project schedules and managing projects.
- Substantial understanding of domestic and global development and implementation of labeling.
- Substantial understanding of medical and/or pharmaceutical regulations and standards.
- Substantial knowledge of EW standards and FDA regulations in relations to labeling and documentation.
- Substantial knowledge of medical device documentation development activities.
- Knowledge of ECR, PDM, and CAPA processes.
- Strong leadership skills and ability to influence change.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
- 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.
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 $78,000 to $110,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e. g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers 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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