Sr. Regulatory Affairs Specialist

**Senior Regulatory Affairs Specialist** **Location:** Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required) **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 **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 stages - Author and manage regulatory submissions (including 510(k)s and technical documentation) to secure and maintain product approvals - Communicate FDA and other Health Authority feedback/correspondence to project teams and RA leadership - Support post-market submissions, including progress reports and annual reports - Conduct regulatory assessments for proposed product changes, manufacturing changes, and product transfers - Advise teams on appropriate regulatory pathways to market - Interface and coordinate directly with the FDA and other regulatory agencies on submissions, approvals, and compliance issues - Review 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 Dossiers - Support internal and external audits and inspection readiness activities - Contribute to the development and maintenance of Regulatory Affairs SOPs and processes - Provide guidance and support to junior Regulatory Affairs Specialists and Associates - Participate in continuous improvement initiatives within the Regulatory Affairs department **What You Bring:** - Bachelor’s degree (B.S. or B.A.) in a scientific area preferred; RAC certification desired - Minimum 2+ years of experience in Regulatory Affairs within the FDA-regulated medical device industry - Hands-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 skills - Excellent organizational, planning, and project management abilities - Ability to work effectively in a team environment and provide leadership on projects - Proficiency with personal computer systems and desktop office applications - Sound understanding of scientific and regulatory principles **Why 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. **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