Share this Job

 

 

 

 

Title:  Labeling Specialist

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

PURPOSE OF POSITION:  With limited support and coaching, the Labeling Specialist, Product Development will provide support to the Product Development department in the management and documentation of medical device labeling from product inception to released production drawings.

 

QUALIFICATIONS

 

 

 

Required:

 

  • Vocational training in technical writing, English, science, marketing, regulatory, or quality assurance.
  • A minimum of 5 years of work in a regulated environment; OR equivalent combination of education and experience.
  • Strong proficiency in Microsoft Office Products.
  • Detail oriented with a strong desire to perform technical writing and documentation.
  • Ability to self-manage, solicit input from multiple departments and execute on multiple tasks.

 

Preferred:

  • Experience with medical devices or some regulated type product.
  • Associates Degree minimum.
  • Experience working in technical environment with technical personnel.
  • Experience generating technical documentation and product labeling.
  • Ability to lead meetings and drive toward decisions.
  • Proficiency in SAP or other product lifecycle management software.

 

Skills & Competencies:

 

  • Strong organizational skills.
  • Excellent verbal communication and technical writing skills.
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
  • Proficiency in the use of SAP for document changes.
  • Able to understand product drawings and label layouts.
  • Able to lead meetings by setting agendas, driving decisions, and documenting minutes.
  • Able to interface with external customers/partners to determine project/task needs.
  • Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.

 

RESPONSIBILITIES:

 

  • Own all labeling changes for the EnFuse products.
  • Manage labeling DCO process and assist engineers with execution of DCO’s.
  • Determine required labeling changes by soliciting input from appropriate departments and personnel.
  • Develop new labels as needed for the product.
  • Support the product development engineers and interface with label suppliers to determine label requirements.
  • Interface with Product Managers to gain understanding of Partner labeling needs.
  • Participate as needed in Partner meetings to confirm requirements and discuss label changes.
  • Assist Product Development engineers with technical writing for design control documents.
  • Coordinate with regulatory to understand and implement labeling standards.

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.