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26 days ago
Requirements and responsibilities
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 objectivesProvide 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 outcomesEvaluate the impact of changing regulations on pre- and post-approval strategies and develop solutions to address market access obstaclesLead preparation, compilation, review, and submission of complex regulatory dossiers to FDA, Notified Bodies, and other global authoritiesNegotiate directly with regulatory authorities on complex issues throughout the product lifecycleConduct thorough regulatory assessments for proposed changes to launched products and determine submission requirementsSupport risk-benefit analysis, labeling, claims, and promotional material reviews for regulatory complianceProvide regulatory input on preclinical, clinical, and manufacturing changes and propose filing strategiesMentor junior team members and provide technical guidance to cross-functional product development teamsMonitor and interpret regulatory trends, legislation, and requirements to proactively influence strategySupport internal and external audits, inspections, and post-market surveillance activitiesLead or contribute to SOP development, process improvements, and training programs on regulatory requirementsCollaborate with cross-functional stakeholders (R&D, Clinical, Quality, Marketing) to ensure timely and compliant product registrations and approvalsWhat 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 preferredMinimum of 8 years of regulatory affairs experience in the medical device or pharmaceutical industryDemonstrated expertise in developing and executing complex regulatory strategies for domestic and international marketsStrong knowledge of FDA regulations, EU MDR/IVDR, Health Canada, and other global regulatory frameworksProven ability to lead regulatory submissions, negotiations with authorities, and cross-functional teamsExcellent analytical, strategic thinking, and problem-solving skills with the ability to operate independentlySuperior written and verbal communication skills, including the ability to present complex regulatory concepts clearlyStrong leadership presence with the ability to mentor others and influence at all organizational levelsExperience with eCTD submissions, risk management, change control, and post-market requirementsWhy 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 insurance401(k) with company matchPaid time off (PTO) and holidaysOngoing training and professional development opportunitiesOpportunity to grow within a fast-paced, dynamic company
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