Medical Device Regulatory Affairs Manager

Company Description

CarboFix is a fast-growing company based in Center District, Israel, specializing in developing, manufacturing, and marketing innovative spine and trauma orthopedic implants. The company's focus is on implants made of continuous carbon fiber reinforced polymer for Trauma and Spine Orthopedic Surgery.

Role Description

This is a full-time on-site role for a Medical Device Regulatory Affairs Manager at CarboFix in Center District, Israel. The Regulatory Affairs Manager will be responsible for managing regulatory requirements, preparing regulatory submissions, and overseeing quality systems on a day-to-day basis.

Qualifications

• Regulatory Affairs, Regulatory Compliance, and Regulatory Submissions skills
• Knowledge of Quality System regulations
• Strong attention to detail and accuracy
• Excellent organizational and time management skills
• Ability to interpret and apply regulatory requirements effectively
• Effective communication and interpersonal skills
• Bachelor's degree in a relevant field (e.g., Regulatory Affairs, Life Sciences, Engineering)
• Experience in CE and or FDA applications is a major advantage