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Labeling Project Lead
Madison, WI, US
Engineering
Bachelors Degree
Full Time, Temporary
Manager (Manager/Supervisor)
On-site
Medical Devices and Supplies
First Shift (Day)
Madison, WI, US
Manager (Manager/Supervisor)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Kelly Services is actively looking for a Labeling Project Lead for a long term (1+ years) assignment with one of our global clients located in Madison, WI.
Term: 1+ years
Hybrid work schedule: 3 days onsite; 2 days remote
Pay rate: Open + benefits + PTO
The Labeling Project Lead will be responsible for driving end to end execution of labeling changes that involve product development, regulatory, compliance, and supply chain strategies for both new and commercialized products. They will be accountable for strategic decision making in support of the labeling portfolio and take the lead in designing and coordinating labeling activities.
Key Responsibilities:
- Responsible for labeling project portfolio management across new product development and lifecycle management to support on time launches and design change implementation.
- Partner with Product Development, Supply Chain, Quality, Regulatory, and Marketing to develop labeling strategies and process improvements to support overall business objectives.
- Accountable for completing Design Control documentation and execution for label development.
- Responsible for completion of Label Assessments, redlines of IFU/artwork, IFU Creation forms and ACCLM content sheets/DCAF.
- Coordinate with external partners to translate labeling to support global distribution of product.
- Work with planning for phase in/phase out of changes considering commercial, quality, or regulatory strategies and ensure timely implementation.
- Maintain product label design and process knowledge for responsible platforms.
- Lead projects as appropriate for unplanned event responses or planned changes.
- Accountable for integrating and coordinating impact analysis, response development, communications planning, and execution associated with unplanned events that impact continuity of quality supply.
- Lead and/or support Non conformances /CAPAs related to labeling as needed.
- Know follow local Quality System policies procedures.
Qualifications:
- Education: A minimum of a bachelor s degree in an Engineering field is required.
- A Project Management Professional certificate is preferable.
- A minimum of 4 years of related experience is required.
- At least 1 year of medical device labeling experience is helpful.
- Consistent track record of delivering projects on time and on budget.
- Understanding of compliance requirements for medical devices and labeling.
- Understanding of manufacturing, packaging, and labeling processes within a regulated field. P
- Personal Traits Strong interpersonal and influence skills.
- Excellent communication and presentation skills.
- Ability to lead multiple assignments or projects with sound analytical and problem-solving skills.
- Excellent planning and organization skills.
For immediate consideration, please apply online. This position is recruited for by a remote Kelly office and not your local Kelly branch.
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