Associate Specialist, Regulatory Affairs

BD

Irvine, CA, US
Base: $33.80 - $55.80 usd hourly; bonus/equity: no...
Fully remote
Strong attention to detail
Proficiency in excel and data manipulation
Ability to manage multiple priorities
BD is seeking an Associate Specialist in Regulatory Affairs to support global product distribution and ensure compliance with regulatory requirements. The role requires attention to detail, strong analytical skills, and collaboration with cross-functional teams, with an emphasis on maintaining accurate product data and compliance

Job Summary

  • This role supports global product distribution and ensures ongoing regulatory compliance for BD's Advanced Patient Monitoring team.
  • The position requires managing product data attributes, certificates, and country-specific requirements within internal regulatory systems.
  • BD prioritizes on-site collaboration with a minimum of 4 days in-office presence per week to foster creativity and innovation.

Matching Summary

Match Score: 85

BD is seeking an Associate Specialist in Regulatory Affairs to support global product distribution and ensure compliance with regulatory requirements. The role requires attention to detail, strong analytical skills, and collaboration with cross-functional teams, with an emphasis on maintaining accurate product data and compliance.

Salary

Base: $33.80 - $55.80 USD Hourly; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including compensation and benefits packages

Skills & Requirements

Must-have

  • Strong attention to detail
  • Proficiency in Excel and data manipulation
  • Ability to manage multiple priorities
  • Cross-functional collaboration skills
  • Data entry and validation expertise

Nice-to-have

  • Self-motivated with proactive mindset
  • Results-driven and diligent worker
  • Adaptable to evolving needs
  • Strong written and verbal communication
  • Learning-oriented approach

Key Requirements

  • Bachelor's degree in scientific or engineering field (preferred)
  • Experience in regulatory or compliance-driven environments
  • Knowledge of EU MDR/MDD and FDA regulations
  • Familiarity with UDI requirements and CE marking processes
  • Working knowledge of ERP systems like SAP

Work Rights

Not specified

Tailored Resume

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