Sr. Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistLocation: Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required)Company: VB SpineLooking 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 Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets.What You'll Do:Participate on cross-functional product development teams to ensure US, EU, and international regulatory requirements are incorporated from the earliest stagesAuthor and manage regulatory submissions (including 510(k)s and technical documentation) to secure and maintain product approvalsCommunicate FDA and other Health Authority feedback/correspondence to project teams and RA leadershipSupport post-market submissions, including progress reports and annual reportsConduct regulatory assessments for proposed product changes, manufacturing changes, and product transfersAdvise teams on appropriate regulatory pathways to marketInterface and coordinate directly with the FDA and other regulatory agencies on submissions, approvals, and compliance issuesReview and approve Engineering Change Notices (ECNs), labeling, collateral materials, and Instructions for Use (IFUs)Maintain regulatory information systems, US product listings, and CE Mark Technical Files / Design DossiersSupport internal and external audits and inspection readiness activitiesContribute to the development and maintenance of Regulatory Affairs SOPs and processesProvide guidance and support to junior Regulatory Affairs Specialists and AssociatesParticipate in continuous improvement initiatives within the Regulatory Affairs departmentWhat You Bring:Bachelor's degree (B.S. or B.A.) in a scientific area preferred; RAC certification desiredMinimum 2+ years of experience in Regulatory Affairs within the FDA-regulated medical device industryHands-on experience preparing and submitting 510(k)s and/or Technical Documentation (required)Working knowledge of US and EU medical device regulations (international experience a plus)Strong interpersonal, written, and verbal communication skillsExcellent organizational, planning, and project management abilitiesAbility to work effectively in a team environment and provide leadership on projectsProficiency with personal computer systems and desktop office applicationsSound understanding of scientific and regulatory principlesWhy VB Spine? We believe in growing talent from within. At VB Spine, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance — positioning yourself for continued growth 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 $100,000.00 - $105,000.00 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.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