Live opening · Posted 3 days ago
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About the role
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Duration: 12+ Months
Location: IN-Warsaw, 100% Remote
Overview: Every Turnberry consultant belongs to a practice, an internal group of consultants and leaders with shared experience and expertise. Each of these practices aligns to one of the core services Turnberry offers to clients. As a Labeling and Packaging Specialist, you will join Turnberry's Business Transformation practice. Turnberry's Business Transformation practice is dedicated to diagnosing and addressing core business challenges including regulatory compliance, full-scale implementation, managing change and driving continuous improvement across transformation initiatives.
Responsibilities
Serve as the Global Labeling and Pacakging team member for Labeling and Packaging development initiatives, including but not limited to NPD (new product development), M&A, CPI (Core product improvement) and UDI tasks
Work with Regulatory, Development, Brand, Manufacturing, and Other departments to develop/create labeling and packaging that complies with US, EU, and UDI labeling and packaging regulations and requirements, as required
Ensure compliant labeling creation, accurate data loaded to labeling systems, approval, maintenance, and label release, including appropriate procedures, work instructions, and forms
Coordinate services and work effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high-quality deliverable for labeling and packaging
Complete Destination labeling, eLabeling for all labeling documents such as but not limited to IFU, Surgical Technique, create Material specification and formats for printed IFU
Demonstrate medical packaging design and development execution within a multi-disciplinary project team desired with minor guidance
Assist/conduct and own testing to support project activities with minor guidance
Lead design control process related documentation to support projects with guidance
Serve as point of contact for Global Labeling and Packaging Developmet team for M&A sites
If needed, travel to other sites to perform onsite activities like requirement gathering, process understanding or implementation
Qualifications
Broad knowledge and understanding of Product Labeling and Packaging regulations for US and OUS regions
Demonstration of strong problem solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
Strong ability to build and strengthen relationships with other areas of the organization (i.e. Marketing, Packaging, Development, IT) and other Business Sites
Good understanding of medical packaging design and development execution
Good understanding of how labeling systems communicate with other business systems
Exceptional attention to detail, organization, and multi-tasking skills
Understand the overall business environment, the orthopedic industry, and the marketplace
Education:
Bachelor’s degree in Science or Technical field with 0+ years of experience in a labeling or relevant capacity
or Associate degree in Science or Technical field with 4+ years of experience in a labeling or relevant capacity
or High School diploma or equivalent required with 6+ years of experience in a labeling or relevant capacity
The salary range for this role is $60,000 to $90,000 or the hourly equivalent. Pay is based on several factors including but not limited to education, work experience, certifications, etc. In addition to your salary, Turnberry Solutions offers benefits such as a comprehensive healthcare package (medical, dental, vision), disability and group term life insurance, health and flexible spending accounts, a utilization bonus, 401(k) with match, flexible time off for salaried employees, parental leave for salaried employees, and flexible work arrangements (all benefits are subject to eligibility requirements). No matter where or when you begin a career with Turnberry, you'll find a far-reaching choice of benefits and incentives.
At Turnberry, we are committed to creating a positive and connected work environment for all and are fully invested in and focused on hiring and growing a diverse team of high performers. We believe that uniqueness in ideas, experiences, and backgrounds make us a better Turnberry: Turnberry is an Equal Employment Opportunity employer, and recruits, employs, trains, compensates, and promotes regardless of age, ancestry, family medical or genetic information, gender identity and expression, marital, military, or veteran status; national and ethnic origin; physical or mental disability; political affiliation; pregnancy; race; religion; sex; sexual orientation; and any other protected characteristics.
Americans With Disabilities Act (ADA)
Turnberry will provide reasonable accommodation with our application process upon request as required to comply with applicable laws. If you have a disability and require accommodation assistance in this application process, please send an email to our Human Resources department at turnberryhr@turnberrysolutions.com.
Work arrangement
Yes
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