Job description

Job Summary and Primary Responsibilities

• Key stakeholder in defining a new and improved business process to support labeling for implementation to support increased scale of sterile product manufacturing.
• Process owner for all Labeling Design and Development activities
• Consolidating Labeling Requirements from cross functional stakeholders
• Directing label design efforts
• Collaborating with cross functional partners to validate Label Designs (outputs) meet Label Requirements (inputs)
• Supporting team efforts to release label elements (stock , templates, images, BOMs) into the chosen labeling programs
• Serve as point of contact for production label troubleshooting. Will lead issue triage effort to pull in Subject Matter Experts as appropriate (e.g. IT, SAP material master team, Printer technical support, Label software technical support, Label stock provider, etc.).
• Lead remediation effort to merge legacy labels into new labeling processes. This will require dynamic communication skills to support interaction with multiple contract manufacturers using legacy process, as well as project management skills.
• Support of ongoing production for internal manufacturing in Ohio and contract manufacturers within the supply chain.
• Support of Distribution, kitting and bulk packaging operation in Memphis.
• Establish and maintain read/write access of NiceLabel Control center.
• Develop implementation plans for future compliance initiatives that support updates to existing and future labels.
• Collaborate with internal Material Master teams to assure SAP tables are updated sure appropriate translations
• Collaborate on label development activities with Packaging Development Engineers on NPI Projects for alpha and commercial launch timelines
• Internal Audit - responsible for operating under quality system SOPs and field evidence requests from 2nd and 3rd Party auditors
• Collaborate on the resolution of Labeling Related Complaints (from customers) or Service Incident reports (from internal distribution channels) as needed
• Support negotiations with existing and future contract manufacturers to define operational labeling requirements
• Lead continuous improvement efforts to improve efficiencies and reduce operation downtime
• Perform duties in compliance with applicable FDA and international regulations and standards including, but not limited to, ISO 13485 and 21 CFR Part 820.

Required Skills / Capabilities

• Bachelor’s degree or equivalent professional experience

• 5+ years experience in regulated industry labeling management
• Knowledge of best labeling processes and practices
• Effective communication skills with strong confidence to lead project meetings and review boards with groups of cross-functional peers, suppliers, and NuVasive leadership
• Solid understanding of change control fundamentals
• Awareness of software validation requirements as it relates to labeling processes

Education and Experience

• Proficiency in SAP and Nicelabel is highly desirable
• Advanced excel skills for data analysis is highly desirable
• Proficiency with Microsoft Office with a strong ability to write procedures and reports
• Experience with project management principles and systems (e.g. Microsoft Project) is strongly desired
• Prior knowledge of medical device packaging, labeling, labeling management software, UDI, and MDR is highly desired.
• Knowledge of IT systems and infrastructure is pre
• ferred

Travel and/or Physical Requirements

Job Type: Full-time

Pay: $60,000.00 - $90,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Application Question(s):

• What kind of labeling software have you used in the past?
• What experience do you have with labeling design and development?

Education:

• Bachelor's (Required)

Work Location: Remote

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