Lead Spine Clinical Regulatory Scientist (Remote)

VB Spine, LLC; Northern (KY); Hybrid; USD 130,000 - 140,000; Full time

Job summary

VB Spine seeks a Senior Staff Clinical Regulatory Scientist to lead clinical evidence strategies for medical devices, generating CEPs/CERs, PMCF and SSCP documents to enable global market access. This role reports to Medical Affairs within the Spine division and requires collaboration with Regulatory, R&D, and Marketing teams.

You will drive literature reviews, risk-based planning, and regulatory communications, mentoring junior staff while shaping long-term clinical programs across markets with

Qualifications

• Bachelor’s degree in a technical or scientific discipline required; Master’s, Ph.D., or other advanced degree in a health-related field 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.
• 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.

Responsibilities

• 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.

Education

Bachelor’s degree in a technical or scientific discipline

Advanced degree preferred

Job description

VB Spine seeks a Senior Staff Clinical Regulatory Scientist to lead clinical evidence strategies for medical devices, generating CEPs/CERs, PMCF and SSCP documents to enable global market access. This role reports to Medical Affairs within the Spine division and requires collaboration with Regulatory, R&D, and Marketing teams.

You will drive literature reviews, risk-based planning, and regulatory communications, mentoring junior staff while shaping long-term clinical programs across markets with