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Labeling Specialist - Medical Device
Job
Actalent
Carpinteria, CA (In Person)
$62,400 Salary, Full-Time
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Job Description
Description Works with Product Development, Regulatory, Quality, and Marketing on labeling development activities, including print and electronic forms. Essential Functions and Basic Duties Lead cross-functional project teams in the development or modification of labels, including Instructions for Use (IFUs), for new and existing products. Use SolidWorks to create or update label drawings and specifications as required. Prepare change control packages to update labeling materials (drawings, overlays, label data forms, etc.), route for approval, and track status through completion. Work with translation companies to obtain quotes and provide initial label layouts. Work with suppliers to obtain proofs and overlays and inspect labels as required. Interface with design consultants, illustrators, and technical writers to maintain a consistent style across all labels. Create Visual Quality Standards as required. Prepare and submit purchase requisitions as needed. Create and maintain Standard Operating Procedures (SOPs) related to labeling. Prioritize and manage labeling project timelines and deadlines. Learn and apply industry regulatory requirements to labeling assignments. Participate in training related to existing and new products. Manage the BarTender/SAP interface and troubleshoot issues related to label printing and First Article Inspections (FAIs). Develop into a Subject Matter Expert (SME) on the electronic labeling system. Assist other sites with the development of electronic labeling systems. Skills Labelling, Regulatory, Medical device, 9001, 13485, BarTender, adobe, SAP, FDA, sop, graphic design Top Skills Details Labelling,Regulatory,Medical device Additional Skills & Qualifications Education Bachelor's degree in Graphic Design or a related discipline; equivalent work experience may be considered. Required Knowledge and Experience Working knowledge of: BarTender and Librarian Adobe InDesign Adobe Photoshop Adobe Acrobat Pro Microsoft Office SolidWorks Familiarity with SAP. Experience working in a regulated environment such as:
FDA ISO 13485 ISO 9001
Experience Level Intermediate Level Job Type & Location This is a Contract position based out of Carpinteria, CA. Pay and Benefits The pay range for this position is $30.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Carpinteria,CA.