Sr. Regulatory Affairs Specialist

2 weeks ago

Leesburg, VA, United States VB Spine LLC Full time
Senior Regulatory Affairs Specialist

Location: 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 Senior Regulatory Affairs Specialist to plan, organize, and implement strategies that secure global regulatory approvals for innovative spinal medical devices and combination products. In this role, you'll partner with cross-functional teams, support submissions to FDA and international authorities, and ensure compliance across the product lifecycle-all while providing leadership and guidance to junior Regulatory Affairs colleagues.

What You'll Do:

  • Develop and implement regulatory strategies for new and revised product lines
  • Prepare, author, and submit regulatory documents (e.g., 510(k), IDE, PMA, CE Technical Files, Design Dossiers)
  • Lead U.S. and EU market approval processes and ensure compliance with regulatory standards
  • Support post-market submissions (progress reports, annual reports, etc.)
  • Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers
  • Communicate and negotiate with FDA and international regulatory authorities
  • Review and approve labeling, IFUs, and promotional materials
  • Establish and maintain regulatory information systems
  • Interpret new or existing regulations and ensure business practices align with compliance requirements
  • Mentor and provide guidance to Regulatory Affairs Specialists/Associates
  • Contribute to continuous improvement initiatives and process optimization within RA
What You Bring:

  • Bachelor's degree in a scientific area (RAC certification preferred)
  • 3+ years of experience in a regulated FDA environment (medical devices or combination products)
  • Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus)
  • Strong understanding of FDA and EU medical device regulations (international experience desirable)
  • Direct experience interacting with FDA reviewers/inspectors
  • Strong organizational, communication, and planning skills with proven ability to lead team initiatives
  • Proficiency with PC systems and office applications
  • Solid understanding of scientific principles applied to regulatory affairs
Why VB Spine?

We believe in growing talent from within. At VB Spine, you'll join a high-performing team, benefit from peer and executive mentorship, and gain opportunities to shape strategy in the dynamic medical device industry-positioning yourself to make a meaningful impact on growth and innovation.

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 $100,000 - $110,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers 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, mission-driven company

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