Position : Product Labelling Work Stream Lead (WSL)

Location : Covington, GA

Duration : 12 Months

Total Hours/week : 40.00

1^st Shift

Client: Medical Device Company

Job Category: Technical Team

Level of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Job Description:

• A successful applicant for the Product Labelling Work Stream Lead (WSL) position must possess a mix of highly technical skills in project management and label design along with some creativity. Must have Project Management skillset to lead all aspects of the creation, release, and the implementation of Instructions for Use (IFU) [aka DFU], package labels, translations, and other relevant labelling components/processes.
• He/she must be able to work quickly, but also remain very thorough and able to produce ACCURATE and COMPLIANT labelling.
• The Labelling Work Stream Lead must be able to work with cross-functional teams to develop, design, and implement medical device product labelling that align with global regulatory requirements are met such as CFR 801 (US) Medical Device Labelling, ISO 15223 Medical Device Symbols, and EU-MDR (Medical Device Regulations).
• The WSL must be a strong leader in the labelling field.
• Strong typographic and layout skills, strict attention to detail, and outstanding interpersonal, project management, file-organization and archiving skills are a must. Strong communication skills and able to lead and be responsible for the labelling workstream for labelling projects.
• This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k).
• Eligibility for these benefits will be based on the eligibility requirements as determined by the client Total Rewards policy and is anticipated to last approximately through 9/30/23.

• The job requirements for the Product Labelling Work Stream Lead position are not limited to the following, but minimally must have the ability to:
• Lead the product labelling workstream from initiation to implementation
• Facilitate the development of the labelling requirements for new products or revisions to current products.
• Collaborate closely with the project manager and project team members from Marketing, Regulatory, R&D, Packaging, Quality Assurance, and Operations ensuring compliance to UDI and EU-MDR requirements.
• Prepare and lead labelling project schedules and communicate labelling schedules to the project team
• Facilitate redlining and the development of content for labelling; lead the labelling process for approvals of labelling; complete labelling design; and ensure implementation of labelling at the manufacturing site.
• A Bachelor’s degree required, preferably in Graphic design or related field with a proven experience in print production and labelling design within a regulated medical/pharmaceutical industry strongly preferred.
• The applicant must have a solid knowledge of the printing process and should be adept with software applications such as the Adobe Creative Suite and Microsoft Office Suite including Microsoft Project and Microsoft Teams.