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 #J-18808-Ljbffr