Regulatory Affairs Senior Director, Digitalization

BD

Franklin Lakes, NJ, USA
Base: $230,300.00 - $368,500.00 usd annual; bonus/...
Hybrid
15 years it experience with gxp csv sdlc
Medical device regulatory affairs expertise
Business operations management budget planning
This role is responsible for establishing and maintaining the central regulatory affairs strategy for digital tools across global business units and regions

Job Summary

  • This role is responsible for establishing and maintaining the central regulatory affairs strategy for digital tools across global business units and regions.
  • The position requires a minimum of 15 years of experience working with IT to launch and maintain RA systems following GxP, Computer Systems Validation, and Software Development Lifecycle standards.
  • BD offers a competitive compensation package including an annual bonus potential, discretionary LTI bonus, and comprehensive health and well-being benefits.

Matching Summary

This role is responsible for establishing and maintaining the central regulatory affairs strategy for digital tools across global business units and regions.

Salary

Base: $230,300.00 - $368,500.00 USD Annual; Bonus/Equity: Annual Bonus Potential; Discretionary LTI Bonus Potential; Benefits: Comprehensive health, wellness, retirement, and life balance programs

Skills & Requirements

Must-have

  • 15 years IT experience with GxP CSV SDLC
  • Medical Device Regulatory Affairs expertise
  • Business operations management budget planning
  • Digital platform management and optimization
  • Cross-functional leadership in matrixed environment

Nice-to-have

  • AI incubation and execution experience
  • Agile problem-solving capabilities
  • Strategic vision refinement skills
  • Data-driven decision-making focus

Key Requirements

  • Bachelor's degree in science, engineering, or technology required
  • Minimum 15 years experience with IT and RA systems
  • Minimum 15 years in business operations management
  • Minimum 5 years in Medical Device industry
  • Master's degree preferred in business, management, or technology

Work Rights

Not specified

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