Sr. Regulatory Affairs Specialist
- Pay
- $100,000 – $105,000 per year
- Location
- Allendale, NJ
- Listed
- Today
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
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
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.
About the company
- 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.
From Vb Spine's careers page, first listed on Rolev.ai on November 12, 2026. Rolev.ai is not the employer.
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Common questions
What is the salary for the Sr. Regulatory Affairs Specialist role at Vb Spine?
The Sr. Regulatory Affairs Specialist posting at Vb Spine states compensation of $100,000 – $105,000 per year. Final pay may depend on location, experience, and interview evaluation on Vb Spine's official career site.
Where is the Sr. Regulatory Affairs Specialist job at Vb Spine located?
This Sr. Regulatory Affairs Specialist position at Vb Spine is located in Allendale, NJ. Always check Vb Spine's application page for specific state eligibility or relocation policies.
How do I apply for the Sr. Regulatory Affairs Specialist position at Vb Spine?
This listing links directly to Vb Spine's Rippling application page. You can apply directly on Vb Spine's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Rippling application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.