Product Labeling Coordinator

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

• Gather and verify information required for program specific labels
• Create and maintain label files in designated software system which meet marketing, manufacturing, engineering, and regulatory requirements
• Create and maintain component specifications for product labels
• Ensure label formats are standardized, where applicable
• 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
• Complete label verifications by coordinating label printing with manufacturing resources
• Work with Engineering to specify appropriate printing technology so that labels can be printed as required

Change Control

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

Regulatory Master Data

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

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

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

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


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