NeuWave Medical Inc, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Labeling Project Lead to join the NeuWave Operations team in Madison, WI!
NeuWave, part of Johnson & Johnson MedTech, has made significant contributions to the field of microwave ablation for over 10 years. The team has developed and released US market-leading thermal ablation devices, offering comprehensive solutions that allow physicians to ablate lesions of many shapes and sizes with predictability and precision.
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.
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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 Nonconformances /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.
Experience and Skills:
- A minimum of 5 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.
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.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.