Senior Staff Toxicologist

Senior Staff Toxicologist

Location : Leesburg, VA or Allendale, NJ
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 looking for driven individuals ready to learn quickly, adapt under pressure, and grow in a dynamic, fast-paced environment. As a Senior Staff Toxicologist, you'll play a critical role in ensuring the biosafety of medical devices by shaping biocompatibility strategies, performing toxicological risk assessments, and leading regulatory submissions for global markets. Candidates should ideally be located in or around Leesburg, VA or Allendale, NJ preferred.

What You'll Do:

• Lead the development of biocompatibility strategies and toxicological risk assessments in accordance with ISO 10993-1, [click to reveal phone number]10993-17 , and ISO 14971.
• Develop and review risk assessments, evaluation plans, and biosafety/efficacy documentation for FDA and international regulatory submissions.
• Manage external lab testing and ensure high-quality, standards-compliant data for regulatory use.
• Interpret extractables/leachables data and chemical characterization results for medical devices.
• Advise cross-functional teams (R&D, RA, Ops) on biosafety strategies for new product development and changes.
• Act as subject matter expert in root cause analysis, process improvement, and design controls related to toxicology.
• Support internal audits (FDA, BSI, GMED) and participate in change control board activities.
• Maintain and improve SOPs/WIs in alignment with evolving global standards and regulations.
• Own NC/CAPA activities related to toxicology and biological safety.
• Communicate toxicological findings clearly to cross-functional stakeholders, leadership, and regulatory bodies.

What You Bring:

• Bachelor's or Master's degree in Pharmacology or Toxicology.
• Board Certification: Diplomate of the American Board of Toxicology (DABT) required.
• Minimum 6 years of experience as a toxicologist, including 4+ years in the medical device industry.
• Extensive experience with toxicological risk-based assessments, biological safety evaluations, and regulatory submissions.
• Expert knowledge of ISO, AAMI, USP, ANSI, and EU guidance for medical devices.
• Experience interacting with regulatory bodies such as FDA, GMED, BSI, or TUV.
• Proven ability to evaluate complex E&L data and unexpected biological responses.
• Strong cross-functional communication and presentation skills.

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high-performing team, benefit from peer and executive mentorship, and shape strategy in the dynamic field of medical devices-positioning yourself to influence growth and innovation across the organization.

Compensation:

Pay for this role is competitive and based on experience, with additional factors like location, qualifications, and performance taken into account. The typical pay range for this position is $140,000 - $160,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis.

Benefits Include:

• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development
• Opportunity to grow within a fast-paced, mission-driven organization