100% remote

8600 – 9500 zł brutto

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.

Requirements:

• 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.

What we offer:

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