Senior Regulatory Affairs Specialist

Location: Leesburg, VA

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 seeking a Senior Regulatory Affairs Specialist to plan, organize, and implement strategies that secure global regulatory approvals for innovative spinal medical devices and combination products. In this role, you’ll partner with cross-functional teams, support submissions to FDA and international authorities, and ensure compliance across the product lifecycle—all while providing leadership and guidance to junior Regulatory Affairs colleagues.

What You’ll Do

• Develop and implement regulatory strategies for new and revised product lines
• Prepare, author, and submit regulatory documents (e.g., 510(k), IDE, PMA, CE Technical Files, Design Dossiers)
• Lead U.S. and EU market approval processes and ensure compliance with regulatory standards
• Support post-market submissions (progress reports, annual reports, etc.)
• Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers
• Communicate and negotiate with FDA and international regulatory authorities
• Review and approve labeling, IFUs, and promotional materials
• Establish and maintain regulatory information systems
• Interpret new or existing regulations and ensure business practices align with compliance requirements
• Mentor and provide guidance to Regulatory Affairs Specialists/Associates
• Contribute to continuous improvement initiatives and process optimization within RA
  
  

What You Bring

• Bachelor’s degree in a scientific area (RAC certification preferred)
• 3+ years of experience in a regulated FDA environment (medical devices or combination products)
• Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus)
• Strong understanding of FDA and EU medical device regulations (international experience desirable)
• Direct experience interacting with FDA reviewers/inspectors
• Strong organizational, communication, and planning skills with proven ability to lead team initiatives
• Proficiency with PC systems and office applications
• Solid understanding of scientific principles applied to regulatory affairs
  
  

Why VB Spine?

We believe in growing talent from within. At VB Spine, you’ll join a high-performing team, benefit from peer and executive mentorship, and gain opportunities to shape strategy in the dynamic medical device industry—positioning yourself to make a meaningful impact on growth and innovation.

Compensation

Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. The typical pay range for this position is $100,000 - $110,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers experience level, skillset, 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, mission-driven company