What are the responsibilities and job description for the Staff Regulatory Affairs Specialist position at VB Spine LLC?
Staff Regulatory Affairs Specialist
Location: Allendale, NJ or Leesburg, VA (hybrid)
Company: VB Spine
Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-driven team dedicated to supporting surgeons during life-changing spinal procedures. We’re seeking a Staff Regulatory Affairs Specialist to help ensure our innovative spinal technologies meet global regulatory requirements. This role plays a key part in securing approvals for new and revised products while ensuring compliance with U.S., EU, and international standards.
What You’ll Do:
- Plan, organize, and implement strategies to obtain regulatory approvals for new and modified medical devices and combination products
- Participate on product development teams to ensure regulatory requirements (U.S., EU, and international) are integrated throughout the design and development process
- Prepare and author regulatory submissions, including 510(k)s and other filings, to obtain market clearance or approval
- Support post-market activities, including progress and annual reports, as well as labeling and promotional material reviews
- Advise cross-functional teams (R&D, Quality, Manufacturing, Marketing) on regulatory pathways and impact assessments for product or process changes
- Interface and coordinate directly with the FDA and other regulatory agencies regarding submissions, approvals, or compliance matters
- Maintain and update regulatory documentation systems, product listings, and technical files (including CE Mark Technical Files and Design Dossiers)
- Interpret new and existing regulations, communicating requirements to internal stakeholders
- Contribute to the development, implementation, and maintenance of regulatory SOPs and continuous improvement initiatives
What You Bring:
- Bachelor’s degree in a scientific field preferred; RAC certification a plus
- Minimum 3 years of experience in the FDA-regulated medical device industry
- Proven experience preparing and submitting 510(k)s; IDE and PMA experience a plus
- Strong understanding of FDA and EU Medical Device Regulations (international experience a plus)
- Experience interacting directly with FDA reviewers or inspectors
- Excellent organizational, communication, and interpersonal skills
- Team-oriented mindset with ability to influence and collaborate cross-functionally
- Proficient with computer systems and standard office applications
- Sound understanding of scientific and regulatory principles
Why VB Spine?
We believe in growing talent from within. At VB Spine, you’ll join a high-performing team, benefit from mentorship, and shape the future of spinal innovation. You’ll gain exposure to cutting-edge products and global markets, positioning yourself for professional growth and impact.
Compensation:
Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, 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
- Opportunity to grow within a fast-paced, dynamic company
