Global Labeling Associate

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Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field.  Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

As a Global Labeling Associate, you will work onsite at our global headquarters within the Global Labeling team. The Global Labeling Associate’s primary responsibilities include creating, updating, and ensuring the accuracy and compliance of labels and IFU artwork. You will review, evaluate, and generate responses to routing documents to confirm adherence to internal standards, global regulations, and project specifications through standard operating procedures, quality instructions, and drawings. A Global Labeling Associate will identify non-conforming artwork, coordinate and oversee solution-oriented documentation, and perform the final review and proofreading prior to routing for approval.

Key Responsibilities: 

• Document Management: Organizing and maintaining document repositories, ensuring easy access, version control, and compliance with document retention.
• Collaboration: Working closely with subject matter experts, project managers, and other stakeholders to gather information and ensure that documentation meets their needs and expectations.
• Communication: Communicating effectively with team members and stakeholders to clarify requirements, address concerns, and ensure alignment on documentation deliverables.
• Documentation Standards Development: Contributing to the development and improvement of documentation standards, templates, and processes to enhance efficiency and consistency.
• Process Improvement: Identify opportunities to enhance documentation processes, proposing and implementing improvements to increase efficiency and effectiveness.

Performance Objectives:

Within your first 30 days: 

• Learn about Applied’s mission and vision, and take part in a variety of Applied Learning foundational courses.  
• Discuss your goals and expectations with your team leader(s) and read and review all relevant team resources and materials. 
• Immerse yourself in team meetings and discussions. 
• Exhibit a strong technical understanding of team’s internal processes.
• Support team meetings and agendas. 
• Create documents and artwork with high guidance and oversight from team leadership.
• Take on document review with high guidance and oversight from team leadership.  

Within 60 days: 

• Initiate the creation and updating of documents and artwork with moderate guidance and oversight from team leadership.
• Take ownership of document review with moderate oversight from team leadership.
• Understand and follow Applied Medical’s Quality System.
• Engage in providing constructive feedback and constructive communication on team efforts.
• Deliver effective timelines for active projects and documents routing.
• Monitor the impact of changes and gather feedback from team members on the effectiveness of Global Labeling’s documentation processes. 

Within 90 days to one year: 

• Self-sufficient or low guidance for reviewing all document types.
• Independently initiate artwork creation and/or updates.
• Cultivate strong interpersonal connections to enhance the success and efficiency of collaborative efforts.
• Showcase a well-rounded and diverse portfolio of documents that demonstrate mastery of various documentation types and styles.
• Demonstrates a clear understanding of labeling requirements and ensures compliance with regulations, ISO standards and internal procedures.

Position Requirements

• Efficient organizational capabilities.
• Exceptional written and oral communication skills, particularly in writing, editing and proofreading. 
• Able to self-manage and work successfully as independent contributor. 
• Administrative support experience. 
• Proficient in MS Office programs like Outlook, Word, Excel, and PowerPoint.  
• Strong attention to detail. 

Preferred

• College degree preferred.

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of excellence at Applied Medical. Our unique business model empowers our team members to have a substantial impact, unlike conventional roles. 

Benefits

• Competitive compensation range: $20 - $28 / hour (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

Salary : $20 - $28