Senior Regulatory Affairs Specialist

Company Description Group is a global solutions provider for the MedTech industry. Through its Manufacturing Solutions and Integrated OEM Solutions business units, the company supports leading OEMs in delivering breakthrough medical devices that improve patient outcomes worldwide. EXALTA Group is committed to advancing medical technology and enhancing patient care on a global scale.

Role Description

This is a full-time remote role for a Senior Regulatory Affairs Specialist. The individual in this role will be responsible for managing regulatory documentation, ensuring regulatory compliance, understanding regulatory requirements, overseeing regulatory affairs, and managing regulatory submissions. Additional responsibilities include advising on regulatory strategies and facilitating communication with regulatory agencies.

Qualifications

• Experience in managing regulatory documentation and regulatory submissions
• Knowledge of regulatory compliance and regulatory requirements
• Proficiency in regulatory affairs and understanding of regulatory frameworks
• Excellent written and verbal communication skills
• Ability to work independently and remotely
• Strong organizational and project management skills
• Bachelor's degree in a relevant field; advanced degree preferred
• Experience in the MedTech industry is a plus