The role involves developing and implementing clinical evidence strategies to support global regulatory submissions and product development. You will oversee the creation of clinical regulatory documentation and collaborate with cross-functional teams to ensure device safety and performance.
What You’ll Do:
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
What You Bring:
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
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
Why VB Spine?
We believe in growing talent from within. At VB Spine, join a high-performing Medical Affairs team where you’ll play a critical leadership role in generating and defending the clinical evidence that enables safe, effective spinal technologies to reach patients worldwide.
Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $130,000.00 - $140,000.00 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, and market conditions.
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
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