Regulatory Affairs Specialist I

📋 Description

• Assist in preparing various submissions to gain approvals, such as 510(k), CE Mark Technical
• Assist in the tracking of multiple projects concurrently
• Ensure that submission/approval documentation is maintained per internal procedures
• Support in-country RA personnel to facilitate global clearance/approvals
• Research and obtain information on Regulatory Intelligence
• Support labeling reviews

🎯 Requirements

• A Bachelor’s degree in a relevant discipline or equivalent combination of education and experience
• Regulatory Medical Device experience preferred
• Proven ability to use and apply technical standards, principles, theories, concepts, and techniques
• Excellent written, oral, and interpersonal communication skills
• Proficiency in Word, Excel, PowerPoint and other computer tools

🎁 Benefits

• Collaborative teamwork environment with constant learning and performance rewards
• Opportunity to be part of team revolutionizing treatment of devastating diseases
• Medical, dental, vision, life, AD&D, short and long-term disability insurance
• 401(k) with employer match
• Paid parental leave
• Eleven paid company holidays per year