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BD

Associate Specialist – Regulatory Affairs

BD

. Support global product distribution and ensure ongoing regulatory compliance .

Posted 4/29/2026full-timeIrvine • California • 🇺🇸 United StatesJuniorMid-Level💰 $34 - $56 per hourWebsite

Tech Stack

Tools & technologies
ERP

About the role

Key responsibilities & impact
  • Support global product distribution and ensure ongoing regulatory compliance
  • Manage product data attributes, certificates, and country-specific compliance requirements
  • Ensure products meet all applicable regional regulatory requirements
  • Maintain accurate product and regulatory data
  • Collaborate with cross-functional teams including Master Data Management and Corporate Regulatory Affairs
  • Perform data entry, data validation, tracking, and reporting within regulatory systems
  • Contribute to the design, testing, and rollout of system updates and enhancements
  • Work effectively with global partners and flex working hours when needed

Requirements

What you’ll need
  • Strong attention to detail with excellent analytical and problem-solving skills
  • Proficiency in Excel and data manipulation tools
  • Bachelor’s degree in a scientific, engineering, or regulatory field (or equivalent experience)
  • Experience working in regulatory or compliance-driven environments
  • Knowledge of EU MDR/MDD, FDA medical device regulations, and other international regulatory frameworks
  • Proven experience collaborating with cross-functional teams in a regulated environment
  • Prior experience with product data management, ERP, or distribution control systems
  • Experience with Master Data Management principles and tools
  • Familiarity with UDI requirements, CE marking processes, and country-specific licensing
  • Working knowledge of ERP system execution and workflows (e.g., SAP)

Benefits

Comp & perks
  • Comprehensive Total Rewards program
  • Reward and recognition opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
data entrydata validationdata manipulationregulatory complianceproduct data managementERP systemsMaster Data Managementanalytical skillsproblem-solving skillstracking and reporting
Soft Skills
attention to detailcollaborationflexibilitycommunication