Labeling Project Lead — Regulatory Packaging Specialist

Sunmed Llc; Grand Rapids (MI); On-site; USD 55,000 - 75,000; Full time

Job summary

The Labeling Specialist role at SunMed Llc in Grand Rapids, MI leads labeling projects and ensures compliance with packaging and labeling regulations. You will manage document change requests and coordinate with manufacturing, regulatory, and quality teams.

Requires 1–3 years labeling experience, familiarity with GDP, GMP, and standards such as ISO 13485 and FDA QSR. Bachelor’s or an equivalent degree is preferred.

Qualifications

• 1–3 years labeling experience, preferably in medical device.
• Knowledge of ISO 13485, FDA QSR, EU Medical Directives and Canadian Medical Device Regulations.
• Knowledge of GDP, GMP, and regulated Quality Systems.
• Bachelor’s or associate Degree and/or equivalent work experience.

Responsibilities

• Create/update product labeling using labeling software (Bartender, Loftware, etc.).
• Lead labeling projects including updates, transfers, and compliance changes.
• Issue and manage labeling DCRs within eQMS Grand Avenue.
• Coordinate label changes with manufacturing plants.
• Manage inventory depletion with plant buyers.
• Clearly communicate project status, timelines, and risks.

Skills

Project leadership

Cross-functional collaboration

Verbal & written communication

Attention to detail

Microsoft Office

Global coordination

Education

Bachelor’s or Associate Degree

Tools

Bartender

Loftware

eQMS Grand Avenue

Job description

The Labeling Specialist role at SunMed Llc in Grand Rapids, MI leads labeling projects and ensures compliance with packaging and labeling regulations. You will manage document change requests and coordinate with manufacturing, regulatory, and quality teams.

Requires 1–3 years labeling experience, familiarity with GDP, GMP, and standards such as ISO 13485 and FDA QSR. Bachelor’s or an equivalent degree is preferred.