Labeling Associate

Applied Medical Distribution Corporation Rancho Santa Margarita , CA 92688

Posted 3 months ago


Applied Medical is a new generation medical device company with a proven business model and commitment to innovation that has fueled our rapid business growth and expansion. Applied Medical has been developing and manufacturing advanced surgical technologies for over 30 years and has earned a strong reputation in healthcare. Our dedication to delivering the highest quality products and unique business positioning, provides our team members with the unique ability to contribute in a larger capacity than is possible in typical companies.

Position Description

In Clinical Development, we are like family. We genuinely care about the development of each team member and the quality of their workday. As a part of our team, you will engage in thought-provoking conversations with a variety of departments and will assist in projects to create or improve innovative processes.

We are looking for individuals who will own, facilitate and carry out deliverables associated with label creation and maintenance across all Applied Medical products. This individual should be able to continually evaluate and enhance the label process and will partner with like-minded team members across departments like Regulatory, Branding and Engineering to ensure compliance to regulatory requirements and coordinate projects for streamlined implementation. As a member of our team, you will be responsible for working in a collaborative environment and performing the following activities:

  • Coordinate labeling projects to ensure regulatory compliance

  • Facilitate project completion through effective and detailed project management

  • Provide guidance to team members on labeling regulations and process requirements

  • Carry out project deliverables such as initiating, reviewing and implementing label creation/updates with extreme attention to detail

  • Identify and recommend process improvements to enhance business practices

  • Provide regular updates regarding labeling projects to cross functional departments to facilitate coordination for project completion timelines

  • Forge relationships with thought leaders in their respective departments to enhance understanding of process needs

  • Develop and promote the Applied Medical brand and culture

  • Mentor team members and act as a recognized resource to local team

Position Requirements

This position requires the following skills and attributes:

  • Ability to function well under pressure and balance multiple projects

  • Dedicated, detail-oriented focus in project initiation and review

  • Skills in project management concepts and softwares

  • Participation in project management meetings as the Clinical Development Operations representative

  • Collaboration within a team environment

  • Bachelor's degree or equivalent experience

  • Effective written and oral communication skills and ability to communicate amongst cross functional teams

  • Proficiency with Microsoft Office programs, including but not limited to Word, Excel, PowerPoint and Outlook

Preferred

The following skills and attributes are preferred:

  • Knowledge of global medical device labeling requirements

  • Experience with Product Lifecycle Management (PLM) system

  • Experience with translation activities

Benefits

  • Training and mentorship with ongoing learning and development courses

  • On-campus wellness activities

  • Comprehensive medical and dental coverage

  • Education reimbursement program

  • 401(k) program with employer match

  • Generous holiday and vacation accrual

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Labeling Associate

Applied Medical Distribution Corporation