VB Spine
Overview
Location: Leesburg, VA (hybrid)
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 an
Associate Manager, Regulatory Affairs
to lead regulatory strategy and operations across the product lifecycle. In this role, you’ll mentor regulatory professionals, manage submissions, ensure compliance with FDA and international standards, and serve as a key interdepartmental resource shaping the future of VB Spine.
Responsibilities
Develop and drive domestic and international regulatory strategies for multiple sites
Provide regulatory guidance to product development teams and leadership
Prepare, submit, and manage applications with Health Authorities, including FDA submissions (510(k), IDEs, etc.)
Serve as primary regulatory reviewer for labeling, advertising/promotion, change controls, and quality documentation
Monitor and assess evolving regulatory requirements and implement compliant processes
Mentor and lead a small team of Regulatory Affairs professionals
Represent RA on cross-functional teams and lead site-specific regulatory integration activities
Support corporate and divisional RA initiatives, including training programs and due diligence opportunities
Evaluate regulatory risks and develop innovative compliance strategies aligned with business needs
Qualifications
B.A./B.S. in Science, Legal, Regulatory, or Engineering (Advanced Degree or RAC certification preferred)
7+ years of regulatory experience in medical device or pharmaceutical industries
Strong analytical and strategic thinking skills with proven ability to manage multiple projects
Demonstrated leadership and mentoring abilities
Excellent written and verbal communication skills, with strong attention to detail
Advanced PC skills and ability to work in regulated environments
Knowledge of FDA and international regulatory frameworks, risk management, and submission processes
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 influence strategy in the dynamic field of medical devices—positioning yourself to impact growth and innovation across the organization.
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 $145,000 - $165,000 annually, plus bonus potential and a comprehensive benefits package. 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
#J-18808-Ljbffr
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 an
Associate Manager, Regulatory Affairs
to lead regulatory strategy and operations across the product lifecycle. In this role, you’ll mentor regulatory professionals, manage submissions, ensure compliance with FDA and international standards, and serve as a key interdepartmental resource shaping the future of VB Spine.
Responsibilities
Develop and drive domestic and international regulatory strategies for multiple sites
Provide regulatory guidance to product development teams and leadership
Prepare, submit, and manage applications with Health Authorities, including FDA submissions (510(k), IDEs, etc.)
Serve as primary regulatory reviewer for labeling, advertising/promotion, change controls, and quality documentation
Monitor and assess evolving regulatory requirements and implement compliant processes
Mentor and lead a small team of Regulatory Affairs professionals
Represent RA on cross-functional teams and lead site-specific regulatory integration activities
Support corporate and divisional RA initiatives, including training programs and due diligence opportunities
Evaluate regulatory risks and develop innovative compliance strategies aligned with business needs
Qualifications
B.A./B.S. in Science, Legal, Regulatory, or Engineering (Advanced Degree or RAC certification preferred)
7+ years of regulatory experience in medical device or pharmaceutical industries
Strong analytical and strategic thinking skills with proven ability to manage multiple projects
Demonstrated leadership and mentoring abilities
Excellent written and verbal communication skills, with strong attention to detail
Advanced PC skills and ability to work in regulated environments
Knowledge of FDA and international regulatory frameworks, risk management, and submission processes
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 influence strategy in the dynamic field of medical devices—positioning yourself to impact growth and innovation across the organization.
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 $145,000 - $165,000 annually, plus bonus potential and a comprehensive benefits package. 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
#J-18808-Ljbffr