Sr. Regulatory Affairs Specialist

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