Sr. Regulatory Affairs Specialist

VB Spine; Leesburg (VA); On-site; USD 100,000 - 105,000; Full time

Benefits offered by this job

Comprehensive health, dental, and vis

401(k) with company match

Paid time off and holidays

Ongoing training and professional dev.

Opportunity to grow within a fast‑pace

Job summary

VB Spine in Leesburg, VA is seeking a Sr. Regulatory Affairs Specialist to help plan and execute regulatory strategies for US, EU, and global markets. The role focuses on 510(k) submissions, regulatory reviews, and maintaining compliance across spine products.

You will collaborate with cross-functional teams, communicate with FDA and Health Authorities, and mentor junior staff while shaping our regulatory roadmap and ensuring timely market approvals.

Qualifications

• Minimum 2+ years of Regulatory Affairs experience in FDA-regulated medical device industry.
• Hands-on experience preparing and submitting 510(k)s and/or Technical Documentation.
• Working knowledge of US and EU medical device regulations.
• Strong communication and project management skills.
• Bachelor’s degree in a scientific field; RAC certification desirable.

Responsibilities

• Participate on cross-functional product development teams to ensure US, EU, and international regulatory requirements are incorporated early.
• Author and manage regulatory submissions (510(k)s) to secure and maintain product approvals.
• Communicate FDA and Health Authority feedback to project teams and RA leadership.
• Support post‑market submissions, including progress reports and annual reports.
• Coordinate with FDA and other regulatory agencies on submissions and compliance issues.

Skills

Regulatory affairs

510(k) submissions

Regulatory strategy

Project management

Interpersonal communication

Education

Bachelor’s degree in a scientific area

RAC certification

Job description

Sr. Regulatory Affairs Specialist

VB Spine, Leesburg, Virginia, United States

About this position

Senior Regulatory Affairs Specialist

Location: Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required)

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 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 Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you’ll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets.

What You’ll Do:

• Participate on cross‑functional product development teams to ensure US, EU, and international regulatory requirements are incorporated from the earliest stages
• Author and manage regulatory submissions (including 510(k)s and technical documentation) to secure and maintain product approvals
• Communicate FDA and other Health Authority feedback/correspondence to project teams and RA leadership
• Support post‑market submissions, including progress reports and annual reports
• Conduct regulatory assessments for proposed product changes, manufacturing changes, and product transfers
• Advise teams on appropriate regulatory pathways to market
• Interface and coordinate directly with the FDA and other regulatory agencies on submissions, approvals, and compliance issues
• Review and approve Engineering Change Notices (ECNs), labeling, collateral materials, and Instructions for Use (IFUs)
• Maintain regulatory information systems, US product listings, and CE Mark Technical Files / Design Dossiers
• Support internal and external audits and inspection readiness activities
• Contribute to the development and maintenance of Regulatory Affairs SOPs and processes
• Provide guidance and support to junior Regulatory Affairs Specialists and Associates
• Participate in continuous improvement initiatives within the Regulatory Affairs department

What You Bring:

• Bachelor’s degree (B.S. or B.A.) in a scientific area preferred; RAC certification desired
• Minimum 2+ years of experience in Regulatory Affairs within the FDA‑regulated medical device industry
• Hands‑on experience preparing and submitting 510(k)s and/or Technical Documentation (required)
• Working knowledge of US and EU medical device regulations (international experience a plus)
• Strong interpersonal, written, and verbal communication skills
• Excellent organizational, planning, and project management abilities
• Ability to work effectively in a team environment and provide leadership on projects
• Proficiency with personal computer systems and desktop office applications
• Sound understanding of scientific and regulatory principles

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high‑performing team where you’ll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance — positioning yourself for continued growth in a dynamic, mission‑driven medical device company.

Compensation:

Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $100,000.00 - $105,000.00 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.

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, dynamic company