Regulatory Affairs Specialist / Labeling Specialist

  • Experis
  • Pomona, CA, USA
  • Aug 01, 2020
Full time Government

Job Description

Job Title: Regulatory Affairs Specialist / Labeling Specialist
Location: POMONA, California
Duration: 12+ months

The position of Regulatory Affairs Specialist I, Labeling is within the Toxicology Regulatory Affairs Department. This role creates direct product labeling using specialized software and Microsoft Office applications, routes labeling in the change management system, and interfaces with Engineering and vendors to obtain and approve labeling proofs.
This job description will be reviewed periodically and is subject to change by management.

Creates and/or revises direct product labeling according to the requirements in domestic and international standards and regulations
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 external graphic designers to obtain and approve artwork files and proofs
Assists with review of advertising and promotional labeling to ensure compliance with product claims
Participates in product development projects and post-market projects as extended team member specializing in labeling
Organizes and maintains hard copy and electronic department files, as needed
Adds and maintains labeling information contained in Regulatory Registration Lists and the Global Regulatory Information Database, as needed
Assists in the maintenance of Labeling standard operating procedures, desktop instructions, templates and forms
Assists with investigations and executes corrective actions for Quality Incidents (QIs) and Corrective and Preventive Actions (CAPAs) affecting product labeling
Carries out duties in compliance with established business policies
Demonstrates commitment to the development, implementation and effectiveness of 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 companys policies and practices
Performs other duties and projects as assigned
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.

Bachelor's degree (BS/BA) in a scientific discipline.
One to two years of experience in Regulatory Affairs or related field (Clinical Affairs, R&D, Legal, or Quality Assurance)
One to two years in an IVD or medical device manufacturing environment
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
Demonstrated written and verbal communication skills
Ability to work on multiple projects simultaneously
Possess a high degree of accuracy and attention to detail
Ability to work independently, as well as within a team
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
Proficient with graphics design software

Disha Kakkad
Talent Acquisition Specialist
Experis CORE
Desk # - Extn: 7124

100 Manpower Place, Milwaukee WI 53212

Experis is an Equal Opportunity Employer (EOE/AA)