Sr. Staff Regulatory Affairs Specialist

Sr. Staff Regulatory Affairs Specialist Location: Allendale, NJ, Leesburg, VA, or 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 apply broad and advanced knowledge of regulatory frameworks, requirements, and processes to advise cross-functional teams and leadership on complex projects and strategies — supporting global product development, lifecycle management, and regulatory What You’ll Do: Train and mentor the Regulatory Affairs team on sources, resources, and the status of local, regional, and global regulations Actively participate as a project stakeholder, driving value and meeting planned milestones Develop, update, and lead global regulatory strategies and Regulatory Plans for projects Prepare, submit, and track regulatory applications under review; provide updates to project teams independently Negotiate with regulatory authorities on common issues throughout the submission process Perform and oversee regulatory impact assessments of post-market changes Act as an independent reviewer for peer submissions Support global registration activities by providing data, developing documentation, and coordinating information requests Monitor the regulatory environment and share relevant updates with the broader RA team Review and approve collateral materials, Medical Education materials, and presentations Actively participate in and support external audits Execute acquisition integration strategy post-close under limited supervision Drive process improvements and recommend changes to procedures Advise on regulatory requirements for quality, preclinical, and clinical data in support of submissions and clinical study applications Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies Ensure compliance with post-approval/clearance requirements, labeling, advertising, and promotional materials What You Bring: Bachelor’s degree (B.A. or B.S.) in Science, Legal, Regulatory, Engineering, or equivalent RAC certification preferred Minimum of 7 years of regulatory experience in the medical device or pharmaceutical industry Demonstrated knowledge and skills in regulatory pathways, risk-benefit analysis, submissions, registration, compliance, post-market surveillance, and distribution Ability to operate with appreciable latitude for independent action and decision-making Experience planning, conducting, and overseeing regulatory assignments with limited supervision Strong communication, collaboration, and stakeholder management skills Ability to mentor and potentially oversee the work of Specialists or Senior Specialists Willingness to accept challenging assignments that stretch and build capabilities Why VB Spine? We believe in growing talent from within. At VB Spine, join a high-performing Regulatory Affairs team where you’ll provide senior-level strategic guidance that enables the successful global launch and continued compliance of innovative spinal technologies. Compensation: Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $135,000.00 - $145,000.00 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