What are the responsibilities and job description for the Label Development Coordinator position at Young Innovations?
Job Details
Description
Site Overview:
Since 1900, Young Dental’s philosophy has been to create, innovate, and support the dental industry with exceptional products. Today, we are proud to be one of the world’s largest manufacturers of disposable prophy angles and preventive dental products.
Role Overview:
This role has a primary responsibility of labeling management supporting Young Dental's product lines.
Qualifications
ESSENTIAL DUTIES:
- Conduct standards assessments when new standards/regulations or changes to existing standards/regulations are published. Responsible to assess impact to current product labeling and execute change requests to facilitate labeling updates to meet current regulations.
- Working knowledge of medical device labeling, medical labeling regulations (FDA, MDR, ISO and other global regulations).
- Create labels or update labels as required and facilitate timely transfer to manufacturing environment.
- Create and revise external artwork (boxes, IFUs, externally printed labels, etc).
- Coordinate with the Supply Chain team to ensure correct new or updated external artwork proofs are provided to vendors.
- Ensure product labeling is crafted in accordance with corporate policies.
- Produce product specific content, ensuring product labels are accurate, compliant and maintained.
- Develop, maintain, and communicate labeling timelines and achievements for new product development and line extension projects.
- Strong attention to detail and follow-up.
- Proficient technical writing, copy editing, and verbal communication skills.
- Flexibility to accommodate changing priorities, deadlines, and project needs.
MINIMUM QUALIFICATIONS:
- 3 years of relevant experience, preferably in the medical device industry.
- Minimum of bachelor’s degree or equivalent.
Knowledge, Abilities and Skills
- Knowledge of manufacturing in a regulated environment (FDA, ISO, etc.)
- Knowledge of international standards for labeling
- Ability to work under pressure and time constraints
- Must be well organized, results oriented and have effective problem solving ability
- Ability to be a self-starter, follow-through and to manage multiple tasks along with a strong sense of urgency in accomplishing goals
- Ability to work in a team environment
- Excellent verbal and written communication skills to all levels of the organization
PHYSICAL REQUIREMENTS:
The position requires the ability to sit, stand, stoop, bend, and walk frequently during the shift. The position may require working extended hours or on weekends as needed.
Working Conditions
Manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.
Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.