Senior Clinical Regulatory Scientist

mpanies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Senior Clinical Regulatory Scientist in our CQR - Medical Affairs function within the Spine division, you'll play a pivotal individual contributor role in developing and maintaining high-quality, regulatory-compliant clinical evidence documentation-translating complex scientific data into clear, submission-ready materials that support global product registrations, post-market surveillance, and the ongoing safety and performance of our medical devices.

What You'll Do:
• Draft, author, and maintain Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) Plans and Reports, and Summary of Safety and Clinical Performance (SSCP) documents for new and existing medical devices to support global registrations and periodic updates
• Perform systematic literature reviews: design compliant search strategies, screen articles against inclusion/exclusion criteria, extract and synthesize data, interpret results, and prepare formal summaries and reports
• Analyze current medical and scientific trends, State of the Art, and clinical evidence for specialized spinal indications and techniques
• Assess device compliance with internal and external safety/performance requirements by reviewing, analyzing, and drawing conclusions from relevant clinical evidence
• Collaborate with medical experts and stakeholders to formulate benefit-risk conclusions based on up-to-date regulatory standards
• Identify residual risks, unanswered questions in clinical evidence, and support the design of PMCF activities with Clinical Affairs to address gaps
• Resolve complex document content issues, respond to reviewer questions from internal and external stakeholders, and ensure timely delivery of high-quality submissions
• Lead or facilitate document review discussions and contribute to the development of internal procedures, templates, style guides, and continuous improvement initiatives
• Work cross-functionally with Regulatory, Clinical, Quality, Marketing, R&D, and external partners (e.g., physicians, CROs) to align on clinical evidence strategy and deliverables

What You Bring:
• Bachelor's degree (BA/BS) in a technical or scientific discipline required; Master's, Ph.D., or advanced degree in a health-related field (e.g., RN, BSN, BPharm, MD, MPH) strongly preferred
• Minimum 1+ year of experience in scientific or medical writing (industry, academic research, or post-doc experience); 2+ years in clinical, medical, quality, or regulatory affairs in the medical device industry preferred
• Experience with scientific journals, publication guidelines, literature databases, advanced search strategies, and literature management software
• Good working knowledge of global clinical regulatory requirements and guidance (e.g., MEDDEV 2.7/1 Rev. 4, EU MDR 2017/745, MDCG documents, TG(MD)R) preferred
• Excellent scientific and medical writing skills with the ability to interpret complex data, synthesize results, and communicate clearly, concisely, and accurately
• Strong analytical thinking, attention to detail, and ability to draw valid conclusions from scientific literature and clinical studies
• Proven ability to manage complex deliverables and projects independently while meeting timelines
• Effective collaboration skills with cross-functional internal teams and external stakeholders (e.g., physicians, CROs, regulatory bodies)
• Proficiency in Microsoft Office Suite; technical aptitude and process-oriented mindset
• Ability to exercise independent judgment, facilitate discussions, communicate complex issues effectively (verbal, written, telephonic, electronic), and handle multiple priorities

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 contribute directly to the clinical evidence that supports safe, innovative spinal solutions-positioning yourself for growth and impact in a mission-driven, regulatory-focused medical company.

Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $85,000.00 - $110,000.00 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, advanced degrees, regulatory writing expertise, and market conditions in the New Jersey/Virginia areas.

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