About this opportunity
VB Spine lists this Senior Regulatory Affairs Specialist opportunity in leesburg, Virginia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Join to apply for the Senior Regulatory Affairs Specialist role at VB Spine .
Location : Leesburg, VA
Company : VB Spine
Overview
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.
Responsibilities
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
Qualifications
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 and Benefits
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
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
Additional details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Legal
Industries: Medical Equipment Manufacturing
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Worksite address
leesburg, VA, 22075, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.