Sr. Staff Clinical Regulatory Scientist
About The Position
VB Spine is seeking a Sr. Staff Clinical Regulatory Scientist to join their high-performing Medical Affairs team. In this critical leadership role, you will be responsible for generating and defending the clinical evidence that enables safe, effective spinal technologies to reach patients worldwide. You will act as a dedicated clinical evaluation project manager, driving a coherent clinical evidence strategy throughout the new product development cycle and aligning with marketing, regulatory, clinical research, and preclinical strategies. This role involves developing and implementing comprehensive clinical evidence strategies that meet regulatory requirements, intended use, and risk classification, as well as collaborating cross-functionally to provide input to design teams for global regulatory submissions. You will also develop global clinical development plans for key regions, communicate and negotiate with regulators, and oversee the creation and updating of clinical regulatory documentation. Additionally, you will design and perform literature searches and reviews, analyze current medical and scientific trends, and appraise various data sources to create scientific reviews. You will form conclusions on the benefit-risk profile of devices, identify residual risks, and represent expertise during audits. The role also includes leading complex projects, contributing to departmental strategies, training and mentoring junior team members, and driving innovation.
Requirements
- Bachelor’s degree (BA or BS) in a technical and/or scientific discipline required
- 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
- 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
- Strong ability to work effectively with cross-functional internal and external stakeholders (Regulatory, Marketing, R&D, Physicians, CROs, etc.)
- Experience leading small teams of individual contributors on scientific or technical topics
- Ability to train and mentor junior team members and drive continuous improvement
- Strong presentation skills and proficiency with Microsoft Office Suite
Nice To Haves
- Master’s, Ph.D., or other advanced degree in a health-related field (Engineering, Science, RN, BSN, BPharm, MD, MPH) highly preferred
- 4+ years of experience in scientific or medical writing (or relevant academic/clinical research experience such as PhD, Post-doc, or BSN) preferred
Responsibilities
- Act as a dedicated clinical evaluation project manager, driving a coherent clinical evidence strategy throughout the new product development 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
Benefits
- 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
- Potential for bonuses and incentives
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What This Job Offers
Job Type
Full-time
Career Level
Senior
