Informacje o stanowisku

responsibilities :

• Coordinate medical device and cosmetic regulatory affairs for US and OUS
• Coordinate communication internal and external to the regulatory function
• Implement regulatory strategies
• Support new product introductions and existing product changes
• Partner to determine global regulatory strategy
• Participate in minimum change documentation
• Support risk management files and completion
• Support UDI
• Review and approve product labelling

• Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution
• 1-2 years of regulatory affairs experience in a private, public, government or military environment
• Ability to read, write, and speak English fluently
• Fundamental understanding of US and OUS medical device and cosmetic regulatory affairs
• Certified Regulatory Affairs professional (RAC)
• Advanced degree in scientific discipline
• Experience with regulatory strategy
• Experience with electronic systems (e.g., SAP, data acquisition systems, regulatory databases, UDI systems)
• Strong communication and collaboration skills

• 100% remote work
• Private healthcare
• MultiSport card
• Life insurance
• PowerYou – e-learning platform

• sharing the costs of sports activities
• private medical care
• life insurance

Wrocław - Oferty pracy w okolicznych lokalizacjach