Job Description
Location: Allendale, NJ or 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 Regulatory Affairs Specialist to support product lifecycle management and ensure compliance with global regulatory requirements. In this role, you will assess device changes post-launch, prepare and maintain regulatory submissions, and support interactions with FDA, Notified Bodies, and other regulatory authorities. You’ll play a vital role in ensuring our products remain safe, effective, and compliant throughout their lifecycle.
What You’ll Do - Assess changes made to devices post-launch to determine regulatory impact on clearances/approvals
- Prepare and support regulatory submissions to FDA, Notified Bodies, and other regulatory agencies
- Collect, organize, and maintain files on local, regional, and global regulatory intelligence
- Monitor regulatory environment, including guidance and standards by product type and geography
- Provide input for regulatory classification and jurisdiction of proposed products
- Research requirements for approval pathways, compliance activities, and submission options
- Assist in developing regulatory procedures, SOPs, and documentation practices
- Collect and organize regulatory, quality, preclinical, and clinical data to meet requirements
- Compile materials for pre-submission reports and communications with regulatory agencies
- Track status of applications under review and provide updates to the regulatory team
- Maintain logs of communications and outcomes with regulators and stakeholders
- Support scheduling and preparation of internal and external regulatory meetings
- Collaborate cross-functionally with engineering, quality, clinical, marketing, and legal teams
What You Bring - Bachelor’s degree (B.S. or B.A.) preferred
- 1+ years of experience in Regulatory Affairs, Quality, or Engineering (medical device preferred)
- Knowledge of domestic and international medical device regulations (FDA, EU MDR, etc.)
- Strong verbal, written, and interpersonal communication skills
- Attention to detail with ability to produce accurate, high-quality documentation under tight timelines
- Understanding of related disciplines such as risk management, product safety, and clinical sciences
- Ability to work independently and prioritize multiple tasks in a dynamic environment
- Customer-service orientation with strong collaboration across internal and external stakeholders
- Ability to analyze and resolve non-routine regulatory issues using independent judgment
- Experience with PLM systems and regulatory documentation tools
- Proficiency with Microsoft Office, Teams, Adobe Acrobat Pro, Adobe Illustrator, etc.
Why VB Spine? We believe in growing talent from within. At VB Spine, you’ll join a collaborative, high-performing team, gain exposure to global regulatory frameworks, and support products that transform patient outcomes. Your contributions will ensure compliance and innovation across our product portfolio.
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 $80,000 – $100,000 annually, with bonus opportunities plus benefits. Final compensation is determined on a case-by-case basis and considers experience, 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
- Travel less than 10%
- Opportunity to grow within a fast-paced, dynamic company
Job Tags
Work at office, Local area,