Ra Labeling Compliance & Business Solutions Lead

BD

Franklin Lakes, United States
Base: $132,400.00 - $218,400.00 usd annual; bonus/...
On-site (minimum of 4 days in-office per week)
Labeling regulations and processes
Labeling technology platforms
Eifu solution management
BD is seeking an RA Labeling Compliance & Business Solutions Lead to enhance its regulatory labeling processes. The role involves collaboration with various teams to streamline labeling compliance and technology solutions in the medical device sector

Job Summary

  • The RA Labeling Compliance and Business Solutions Lead will partner with labeling teams, stakeholder groups, and leadership in assessing new challenges and helping to identify and implement solutions.
  • This role reports to BD’s Central Regulatory Affairs team and provides the RA Labeling Compliance and Business Solutions Lead the platform to support BD as the Global Process Owner for eIFU.
  • BD offers a competitive compensation package along with a comprehensive suite of benefits including health and well-being programs, retirement plans, and life balance programs.

Matching Summary

Match Score: 85

BD is seeking an RA Labeling Compliance & Business Solutions Lead to enhance its regulatory labeling processes. The role involves collaboration with various teams to streamline labeling compliance and technology solutions in the medical device sector.

Salary

Base: $132,400.00 - $218,400.00 USD Annual; Bonus/Equity: Annual Bonus and Potential Discretionary LTI Bonus; Benefits: Medical, Dental, Vision, Life Insurance, Disability, Retirement Plans, PTO, etc.

Skills & Requirements

Must-have

  • labeling regulations and processes
  • labeling technology platforms
  • eIFU solution management
  • cross-functional team collaboration
  • stakeholder feedback assessment

Nice-to-have

  • advocate for Regulatory Labeling
  • builds and applies business acumen
  • inspires responsibility for compliance

Key Requirements

  • Bachelor’s degree in a technical, scientific, or other related discipline
  • Minimum of ten years overall professional experience
  • Minimum of five years of direct experience in medical device/pharmaceutical labeling
  • At least five years of direct experience with US, EU, and other global medical device regulations
  • Experience working with FDA and/or EU notified bodies
  • Experience in labeling technology deployment (eIFU, content management system, labeling system, or other)
  • Experience working in a large, complex, and matrixed organization
  • Excellent MS Office Suite skills
  • Excellent analytical skills
  • Experience of working with relational databases (Excel, Power BI)
  • Knowledge of quality system elements (GDP, etc.)

Work Rights

Not specified

Tailored Resume

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