Sr. Clinical Regulatory Scientist

Senior Staff Clinical Regulatory Scientist

Location: Leesburg, VA, Allendale, NJ or Remote | 20% 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 Staff Clinical Regulatory Scientist in our Medical Affairs function within the Spine division, you’ll lead the evaluation and establishment of clinical evidence strategies for new and existing medical devices — creating and maintaining critical documentation such as Clinical Evaluation Plans and Reports (CEPs/CERs), Post-Market Clinical Follow-up (PMCF) documents, and Summary of Safety and Clinical Performance (SSCP) documents to support global market access and ongoing compliance.

• Act as a dedicated clinical evaluation project manager, driving a coherent clinical evidence strategy throughout the product life cycle and aligning with marketing, regulatory, clinical research, and preclinical strategies
• Develop and implement comprehensive clinical evidence strategies that meet regulatory requirements, intended use, and risk classification
• Collaborate cross-functionally to provide input to design teams for global regulatory submissions
• Develop global clinical development plans for key regions, including new and existing markets
• Communicate and negotiate with regulators on clinical evidence requirements to support successful regulatory submissions
• Oversee the creation and periodic updating of clinical regulatory documentation (CERs, CEPs, PMCF Plans/Reports, SSCPs) to validate device safety and performance
• Design compliant and sustainable literature search strategies and perform systematic literature reviews
• Analyze current medical and scientific trends in the clinical state of the art across specialized indications and techniques
• Identify, appraise, and analyze clinical, post-market surveillance, marketing, and preclinical data to create comprehensive scientific reviews
• Form conclusions on the overall benefit-risk profile of devices in collaboration with Medical Experts and other stakeholders
• Identify residual risks and unanswered questions in clinical evidence and partner with Clinical Affairs to design PMCF activities
• Represent expertise during internal and external quality system audits
• Lead complex projects, contribute to long-term departmental strategies, and provide insights on regulatory and clinical trends
• Train and mentor junior team members and drive innovation in internal procedures and best practices

• Bachelor’s degree (BA or BS) in a technical and/or scientific discipline required;
  Master’s, Ph.D., or other advanced degree in a health-related field (Engineering, Science, RN, BSN, BPharm, MD, MPH) highly preferred
• 6+ years of industry experience in clinical, quality, or regulatory affairs (including Risk Management, Design Quality, Post-Market Safety, etc.), with 2–4 years specifically in clinical evaluation within the medical device industry
• 4+ years of experience in scientific or medical writing (or relevant academic/clinical research experience such as PhD, Post-doc, or BSN) preferred
• Expert knowledge and comprehensive understanding of global clinical evaluation regulations required
• Excellent scientific and medical writing skills
• Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, clinical data, and complex technical documents
• Proven track record of successfully managing complex projects
• Stron…