Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist
Location: Remote

Company: VB Spine

Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Principal Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you’ll serve as a senior strategic expert — developing and executing global and regional regulatory strategies, guiding complex submissions, and providing high-level regulatory leadership to support new product development, product lifecycle management, and sustained market access for innovative spinal technologies.

What You’ll Do:

• Develop and update global, regional, and multi-country regulatory strategies, aligning them with organizational and business objectives
• Provide strategic regulatory guidance for new product development, product modifications, and lifecycle management (from launch through obsolescence)
• Assess regulatory pathways for initial product designs and recommend refinements based on evolving regulations and initial outcomes
• Evaluate the impact of changing regulations on pre- and post-approval strategies and develop solutions to address market access obstacles
• Lead preparation, compilation, review, and submission of complex regulatory dossiers to FDA, Notified Bodies, and other global authorities
• Negotiate directly with regulatory authorities on complex issues throughout the product lifecycle
• Conduct thorough regulatory assessments for proposed changes to launched products and determine submission requirements
• Support risk-benefit analysis, labeling, claims, and promotional material reviews for regulatory compliance
• Provide regulatory input on preclinical, clinical, and manufacturing changes and propose filing strategies
• Mentor junior team members and provide technical guidance to cross-functional product development teams
• Monitor and interpret regulatory trends, legislation, and requirements to proactively influence strategy
• Support internal and external audits, inspections, and post-market surveillance activities
• Lead or contribute to SOP development, process improvements, and training programs on regulatory requirements
• Collaborate with cross-functional stakeholders (R&D, Clinical, Quality, Marketing) to ensure timely and compliant product registrations and approvals

What You Bring:

• Bachelor’s degree (B.A. or B.S.) in Science, Engineering, Legal, Regulatory Affairs, or equivalent required; Advanced degree or RAC certification strongly preferred
• Minimum of 8 years of regulatory affairs experience in the medical device or pharmaceutical industry
• Demonstrated expertise in developing and executing complex regulatory strategies for domestic and international markets
• Strong knowledge of FDA regulations, EU MDR/IVDR, Health Canada, and other global regulatory frameworks
• Proven ability to lead regulatory submissions, negotiations with authorities, and cross-functional teams
• Excellent analytical, strategic thinking, and problem-solving skills with the ability to operate independently
• Superior written and verbal communication skills, including the ability to present complex regulatory concepts clearly
• Strong leadership presence with the ability to mentor others and influence at all organizational levels
• Experience with eCTD submissions, risk management, change control, and post-market requirements

Why VB Spine?
We believe in growing talent from within. At VB Spine, join a high-performing team where you’ll provide senior regulatory leadership that directly enables the launch and continued success of life-changing spinal innovations — positioning yourself as a strategic expert in a dynamic, mission-driven medical device company.

Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $150,000.00 - $160,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, regulatory expertise, and market conditions.

Benefits include:

• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities
• Opportunity to grow within a fast-paced, dynamic company