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

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)

Associate Specialist – Regulatory Affairs

Key skills