Job Details

  • Title: Labelling Regulatory Affairs Specialist
  • Code: RCI-24222
  • Location: US-Remote
  • Posted Date: 06/23/2022
  • Duration: 5 Months
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  Job Description

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