Sr. Regulatory Affairs Specialist

Location:

Leesburg, VA, Allendale, NJ, or Remote

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 Sr. Staff Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll apply broad and advanced knowledge of regulatory frameworks, requirements, legislation, and processes to advise cross-functional teams and leadership on complex projects and strategies - supporting global product development, lifecycle management, and regulatory compliance.

• 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
• Define and lead global regulatory strategy and the creation of Regulatory Plans for projects under limited supervision
• Prepare, submit, and track regulatory applications under review and provide updates to project teams independently
• Negotiate with regulatory authorities on common issues throughout the submission process
• Act as an independent reviewer for peer submissions
• Perform and oversee regulatory impact assessments of post-market changes
• Support global registration activities by providing data, developing documentation, and coordinating 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
• Evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure compliance
• Anticipate regulatory obstacles and emerging issues and develop solutions
• Lead SOP development and review
• Provide regulatory strategy and input to new product development and product lifecycle planning
• Evaluate regulatory impact of proposed changes to launched products
• Ensure compliance with post-approval/clearance requirements, labeling, advertising, and promotional materials
• Compile, prepare, review, and submit regulatory dossiers to authorities

• 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
• Strong technical and management skills engaged in regulatory strategy and operations
• Demonstrated knowledge of 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
• Ability to mentor and potentially oversee the work of Specialists or Senior Specialists
• Strong communication, collaboration, and problem-solving skills
• Willingness to accept challenging assignments that stretch and build capabilities

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.

Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $ - $ 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 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