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

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Labeling Specialist

Corporate Quality Full Time Grand Rapids, MI, US

30+ days ago Requisition ID: 1916

Salary Range: $70,000.00 To $75,000.00 Annually

POSITION SUMMARY

The Labeling Specialist will primarily be responsible for leading assigned labeling projects which could include day to day label updates, compliance updates, new business opportunities, manufacturing transfers etc. while ensuring compliance with all packaging and labeling regulations and standards. This position would manage their document change requests for assigned labeling projects and management labeling inventory.

POSITION QUALIFICATIONS

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge:

• Ability to lead and implement cross-functional projects, develop project schedules, and communicate project status.
• Strong interpersonal skills, including effective verbal and written communication.
• Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies – able to do so quickly without sacrificing attention to detail.
• Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.
• Ability to interact effectively with functions of a global organization to achieve goals.

Level of Experience:

• 1 - 3 years of labeling experience, preferably in medical device.
• Ideally possess knowledge of the following standards (e.g. ISO 13485, FDA QSR, EU Medical Directives, and Canadian Medical Device Regulations, Japan, Brazil, Australia) and specific regulations and standards affecting the Packaging and Labeling Quality System (UDI & GSI).
• Knowledge of GDP, GMP, and regulated Quality Systems.

Level of Education:

• Bachelor’s or associate Degree and/or equivalent work experience.

Travel:As the business needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The core tasks, duties, and responsibilities that must be performed on the job.

• Create/update product labeling using labeling software’s (Bartender, Loftware, etc.)
• Labeling lead for assigned Labeling Projects. Labeling projects could consist of day-to-day labeling updates, manufacturing transfers, compliance updates, new business opportunities etc.
• Issue and manage labeling DCRs within eQMS Grand Avenue.
• Coordinates implementation of label changes with manufacturing plants.
• Manages inventory depletion with plant buyers.
• Clearly communicate project status, timelines, and risks regarding labeling projects.
• Works closely and communicates effectively with Regulatory, Engineering, Marketing, Quality, Supply Chain, and Manufacturing teams to develop/revise product labeling content and specifications for: label dimensions, bar code requirements, language translations, country-specific information, type style, font size, clarity and conformity of wording and symbols, formatting, etc).
• Complete labeling according to SunMed brand guidelines, labeling guidelines and regulatory requirements

OTHER RESPONSIBILITIES

• Focus on achieving our Company mission.
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
• Contribute to building and maintaining a positive team environment.
• Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve.We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.

AirLife offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k), paid time off, paid holidays, bereavement leave, Employee Assistance Program resources, and medical leave benefits, subject to applicable eligibility requirements. Certain positions may also be eligible for bonus, commission, or other incentive compensation.