Insulet Corporation Labeling/Promotion Associate in Billerica, Massachusetts

This position supports Marketing, Commercial, Medical Affairs, Purchasing, and Quality Assurance in the review, control, and implementation of advertising, labeling, clinical publication, and vendor control for Insulet Corporation.

  • Maintain compliance with QSR and ISO 13485, all regulatory requirements, and best practices for labeling, promotion, clinical publication, purchasing, and document controls.

  • Provide QA expertise in the review and implementation of marketing materials, labeling changes, promotional materials, websites, apps, trade shows, and published materials.

  • Work with Document Control to properly control all printed and electronic media.

  • Partner with Marketing and Commercial on strategies for upcoming campaigns, shows, and seminars.

  • Manage procedures in accordance with US and ROW requirements.

  • Perform investigations and champion corrective actions when non-conformities arise.

  • Provide assurance that print, electronic, and consulting suppliers are adequately controlled and provide adequate quality assurance in accordance with Insulet procedures.

  • Support Design Quality Assurance and Sustaining Quality.

  • Prepare reports related to Quality Metrics and identify and implement improvements towards meeting those goals.

  • Perform other duties as assigned.

  • BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.

  • Minimum of 3 years in the Medical Device Industry.

  • Minimum of 3 years in the Quality function working with QSR and ISO 13485.

  • Experience with FDA and ISO 13485 inspections preferred.

Skills/Competencies:

  • Effective verbal and excellent technical writing skills.

  • Ability to communicate and work effectively at multiple levels within the organization.

  • Ability to organize and judge priorities.

  • Ability to organize and follow through with tasks with minimal supervision.

  • Excels at generating and maintaining organized and accurate records.

  • MS Office, strong word processing and spreadsheet skills.

Physical Requirements:

  • Some travel may be required

External Company URL: http://www.myomnipod.com/