Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist, Program Lead.

Key Responsibilities

• Author regulatory submissions and support product development for US and international regulatory approval
• Manage and prepare regulatory submissions for device approvals and registrations globally
• Function as a Regulatory Affairs subject matter expert supporting cross-functional partners through design control activities

Required Qualifications

• Master's degree in Pharmacy Administration, Biomechanical Engineering, or a related field
• 4 years of experience in regulatory affairs or a related occupation
• Experience with regulatory submissions and health authority communications
• Knowledge of regulatory requirements for medical devices
• Experience in cross-functional collaboration in product development