Senior Staff Specialist, Regulatory Affairs, Dispensing

Hi Tech IT - An Initiative to Digitise

San Diego, CA, USA
Base: $155,900.00 - $257,300.00 usd annual; bonus/...
Fully remote
Global regulatory strategy development
Medical device regulations compliance
Technical file creation and remediation
This position is responsible for supporting MMS Dispensing products consisting of non-Medical and Medical Devices and associated Software and Accessories on a global basis from a Regulatory Affairs standpoint

Job Summary

  • This position is responsible for supporting MMS Dispensing products consisting of non-Medical and Medical Devices and associated Software and Accessories on a global basis from a Regulatory Affairs standpoint.
  • Support will consist of developing and executing global regulatory strategy to support new product development, sustaining, and end of life activities.
  • At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.

Matching Summary

This position is responsible for supporting MMS Dispensing products consisting of non-Medical and Medical Devices and associated Software and Accessories on a global basis from a Regulatory Affairs standpoint.

Salary

Base: $155,900.00 - $257,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Medical device regulations compliance
  • Technical File creation and remediation
  • Regulatory impact assessments
  • Quality System Medical Device Regulation (QSMR) adherence

Nice-to-have

  • Continuous process improvement
  • Mentoring high performing talent
  • Human element across global teams
  • Imagination and passion for health

Key Requirements

  • Minimum 5 years of directly related Regulatory Affairs experience in medical devices
  • Bachelor's degree in biology, engineering, or other science-related discipline
  • Experience with Regulatory and Quality Information Management systems
  • Digital literacy in MS Word, Excel, PowerPoint, Teams
  • Project Management experience

Work Rights

Not specified

Tailored Resume

Cover Letter