What are the responsibilities and job description for the Associate Manager, Regulatory Affairs position at VB Spine?
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.
What You’ll Do
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
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.
What You’ll Do
- 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
- 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
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
Salary : $145,000 - $165,000