Product Labeling Coordinator Jobs

As a member of our Regulatory team, you will coordinate and verify the information required to use in creating label programs with various stakeholders including marketing, manufacturing, and regulatory, to ensure our labels on products and cartons are accurate for distribution.

Responsibilities Include:

Label Creation

• Work with Engineering to specify appropriate printing technology so that labels can be printed as required
• Create and maintain label files in designated software system which meet marketing, manufacturing, engineering, and regulatory requirements
• Program user interface for label software so user entry is error proofed. When needed create or contract VBA macros for data input manipulation or automation
• Gather and verify information required for program specific labels
• Create and maintain component specifications for product labels
• Ensure label formats are standardized, where applicable
• Complete label verifications by coordinating label printing with manufacturing resources

Change Control

• Assign GTIN / UDI for new or revised labeling, as applicable
• Learn and keep up to date with new regulations affecting label content and databases.
• Enter and maintain labelling information in regulatory agencies Unique Device Identifier (UDI) databases, as required
• Manage GTIN/UDI databases

Regulatory Master Data

• Maintain supplier and part files with accurate and appropriate information
• Help ensure supplier success by assisting in applicable performance measurement systems and feedback.
• Maintain orderly and effective systems for supplier communication.

Department Support

• Provide other support as required or requested by Regulatory Affairs staff

Health and Safety

• Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

QUALIFICATIONS

• Advanced experience in a Windows environment
• Graphic arts experience is an asset
• High attention to detail
• Knowledge and understanding of regulations governing medical devices in Canada, US and Europe is an asset.
• Experience in regulatory affairs is an asset
• Computer literate with:
• Knowledge of the requirements of an ISO 13485 quality program is an asset
• Advanced experience in MS Word
• Experience creating and maintaining label programs and user interfaces is an asset
• Minimum of 1 year of experience in manufacturing industry
• Strong organizational and general administrative skills
• Basic knowledge of Enterprise Resource Planning (ERP) software, e.g. Great Plains Dynamics
• Experience using database software to manage data and records is an asset
• Advanced experience in MS Excel
• Diploma in administration, manufacturing, computer science or related field
• Excellent oral and written communication skills, including technical writing
• Experience in computer programming or MS Excel macro programming
• Strong interpersonal skills with ability to communicate effectively with internal personnel and external parties, e.g., customers

At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.