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