Regulatory Affairs Specialist

About the Company

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. It offers a comprehensive product range spanning trauma and deformity, scoliosis, and sports medicine to improve the lives of children worldwide.

Responsibilities

• Act as the regulatory representative on cross-functional New Product Development teams
• Develop regulatory strategies, testing requirements, and documentation for new and modified products
• Collaborate with product managers to determine country registration needs, timelines, and costs
• Support engineering teams with verification and validation testing plans and review design history files
• Prepare regulatory submissions including 510(k), Letter to File, Health Canada Submissions, and Technical Files
• Maintain databases for UDI, GUDID, licenses, and approvals
• Review and approve product, supplier, and manufacturing changes for regulatory compliance
• Monitor the impact of changing global regulations on submission strategies
• Review and approve device labeling and marketing materials
• Provide regulatory input for product recalls and communications

Requirements

• Bachelor's degree required
• Minimum of 2 years of experience in medical device regulatory affairs preferred
• Fundamental understanding of medical device terminology, anatomy, and regulations
• Strong technical writing and editing skills
• Ability to manage multiple projects and changing priorities under strict deadlines
• Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint
• Valid driver's license