Regulatory Affairs Specialist II

📋 Description

• Prepare moderately complex regulatory submissions (IDE, 510(k), CE-Mark Technical Dossier, UKCA
• Track multiple projects concurrently
• Ensure that existing approvals and documentation are maintained
• Communicate with in-country RA personnel to facilitate global clearance/approvals
• Monitor, research, and obtain information on FDA clearances/approvals of competitors and share with
• Communicate with regulatory agencies under direct supervision

🎯 Requirements

• Bachelor's degree in science discipline or related field with 2+ years of experience, or equivalent
• Regulatory Medical Device experience preferred
• Proven ability to use and apply technical standards, principles, theories, concepts, and techniques
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint

🎁 Benefits

• Collaborative teamwork environment with constant learning and performance rewarded
• Opportunity to be part of the team revolutionizing the treatment of some of the world's most
• 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