Job Details

Remote

Responsibilities:

• Provides labeling regulatory support for diagnostic product development and commercial diagnostic products
• Participates in product development projects and post-market projects as extended team member specializing in labeling
• Creates and/or revises direct product labeling according to the requirements in domestic and international standards and regulations
• Applies US, EU, and international regulations and standards on IVD and MD product labeling to assure compliance with quality and regulatory requirements.
• Ensures labeling artwork to meet all medical, legal and regulatory requirements
• Interfaces with Engineering and Process Improvement departments to determine label specifications and obtain labeling proofs
• Interfaces with Marketing and Commercial teams to support customer and private label initiatives
• Interfaces with vendors and graphic designers to obtain and approve artwork files and proofs
• Manages labeling translations to support country registrations
• Responsible for routing labeling and providing general services to support release of approved labeling for in vitro diagnostic products.
• Assists in the maintenance of Labeling standard operating procedures, desktop instructions, templates and forms
• Assists with review of advertising and promotional labeling to ensure compliance with product claims
• Organizes and maintains hard copy and electronic department files, as needed
• Keeps informed of global regulatory information
• Carries out duties in compliance with established business policies.
• Performs other duties and projects as assigned
• Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
• Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Minimum Qualifications | Education/Experience:

• Bachelor’s degree (BS/BA) in a scientific discipline
• Proficient with Adobe Acrobat, Microsoft Office, including Word, Excel, and Visio
• Demonstrated written and verbal communication skills
• Ability to work on multiple projects simultaneously
• Ability to work independently, as well as within a team

Preferred Qualifications:

• One to two years in an IVD or medical device manufacturing environment
• One to two years of experience in product labeling
• Introductory knowledge of federal and international regulations
• Introductory knowledge of quality systems in a regulated manufacturing environment
• Good knowledge of product labeling and related requirements
• Proficient with graphics design software, such as Bartender
• Possess a high degree of accuracy and attention to detail

Competencies:

• Driven for results
• Teamwork
• Communication
• Initiative