Regulatory Affairs Manager, Global Registrations

Regulatory Affairs Manager, Global Registrations. Establish Labs is changing the medical device industry by designing, developing, and manufacturing innovative medical aesthetic device technologies and wellness solutions.

Requirements

• University Degree in applied science or other related area or equivalent experience
• Knowledge of ISO, FDA, CE Mark, Risk Management and other quality standards and regulations applicable to medical devices
• Computer literacy and basic computer configuration
• Advanced English
• Proficiency in other languages is a plus (French, Portuguese, others)
• Experience in a regulated industry
• Experience working in the Regulatory Affairs areas
• Highly developed soft skills and the ability to communicate effectively both verbally and in writing, with diverse audiences

Benefits

• Equal employment opportunity
• Committed to a more equal opportunity workplace