Product Labeling Coordinator - London, Canada - Trudell Medical International

Trudell Medical International

Verified Company

London, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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._