Labeling Specifications Specialist

Redbock - an NES Fircroft company; Minneapolis, Saint Paul (MN, MN); On-site; USD 65,000 - 95,000; Full time

Job summary

Redbock - an NES Fircroft company seeks a Labeling Specifications Specialist for a 12-month contract in Minneapolis, MN. On-site four days per week, you will ensure accurate labeling for medical products and regulatory compliance.

You will create and review labeling text, monitor regulatory changes, and support labeling processes using PLM systems (Enovia/Windchill) and Adobe Illustrator, with sharp attention to detail.

Qualifications

• Experience with medical package labeling.
• Experience with UDI data, QMS Agile, and data entry/coordination.
• Experience releasing specs/drawings in PLM (Enovia / Windchill).
• Adobe Illustrator experience.
• Proof reading of labels with strong attention to detail.

Responsibilities

• Creates, reviews, and reproduces text required for labeling medical products.
• Ensures labeling, art, film, and plate proofs meet medical, legal, and regulatory requirements.
• Monitors changes in labeling regulations in the US and abroad.
• Reviews promotional material to ensure data support and regulatory alignment.
• Monitors and suggests improvements to labeling processes and tools.

Skills

Artwork & Labeling Development

Enovia

Windchill

Adobe Illustrator

Labeling proofreading

Tools

Enovia

Windchill

Adobe Illustrator

Job description

Labeling Specifications Specialist (12 month contract // Minneapolis, MN):

Candidate is required to work on site 4 days per week

HM's Top Needs:

• Experience with Medical Package labeling
• Experience with UDI Data, QMS Agile, and data entry/coordination
• Experience releasing specs/drawings in a PLM system (Enovia / Windchill)
• Adobe Illustrator experience
• Experience with Proof Reading of labels – requires strong attention to detail

Years’ Experience Required: 2 years of relevant regulatory, quality, and labeling experience

Duties:

• Creates, reviews, and reproduces text required for labeling medical products.
• Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements.
• Monitors changes in labeling regulations in the US and/or abroad.
• Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.
• Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools, and/or policies.

Must Haves:

• Artwork & Labeling Development

Nice to Have:

• Previous experience on Quality Systems & CAPA, Change Control and Validations
• Knowledgeable on Medical Device Regulatory Requirements
• Previous experience with Quality & Regulatory Audit activities