Senior Staff Specialist, Regulatory Affairs, Dispensing

BDX

San Diego, CA, USA
Base: $155,900.00 - $257,300.00 usd annual; bonus/...
Fully remote
Global regulatory strategy development
Regulatory compliance for medical devices
Fda and eu-mdr regulations
This position supports MMS Dispensing products globally from a Regulatory Affairs standpoint by developing and executing regulatory strategies

Job Summary

  • This position supports MMS Dispensing products globally from a Regulatory Affairs standpoint by developing and executing regulatory strategies.
  • BD values a culture that fosters learning, growth, and innovation, encouraging employees to bring their authentic selves to work.
  • BD requires a minimum of 4 days in-office presence per week for most roles to maintain collaboration and culture, with accommodations for remote or field-based positions.

Matching Summary

This position supports MMS Dispensing products globally from a Regulatory Affairs standpoint by developing and executing regulatory strategies.

Salary

Base: $155,900.00 - $257,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive compensation and benefits programs

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Regulatory compliance for medical devices
  • FDA and EU-MDR regulations
  • Technical file creation and remediation
  • Regulatory impact assessments
  • Regulatory and Quality Information Management systems
  • Project management experience

Nice-to-have

  • Mentoring regulatory talent
  • Continuous process improvement
  • Effective internal communication
  • Cross-functional collaboration
  • Digital literacy in MS Office
  • Problem solving and escalation
  • On-site collaboration culture

Key Requirements

  • Bachelor's degree in biology, engineering, or science
  • Minimum 5 years Regulatory Affairs experience
  • Experience with SAP, RIM or related systems
  • Project management experience
  • Advanced degree preferred
  • RAPS RAC certification preferred
  • COVID-19 vaccination or testing requirements

Work Rights

Must be fully vaccinated against COVID-19 or comply with testing requirements

Tailored Resume

Cover Letter