Senior Staff Clinical Evaluation Specialist

Senior Staff Clinical Evaluation Specialist

Requirements

• A Master of Science degree in a health/science-related field required.
• Doctorate degree in health/science-related field preferred.
• 7+ years of industry experience in clinical, quality, or regulatory affairs (risk management, design quality, post-market safety, etc.), including 3 years of experience in writing clinical evaluations for medical devices required.
• Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents required, including ability to apply guidelines/standards toward developing a comprehensive market access strategy.
• Demonstrated ability to understand and communicate new medical topics including disease states, treatment rationales, surgical techniques, and clinical outcomes.
• Demonstrated ability to drive innovation and set direction within the group in internal procedures and best practices.
• Strong communication, project management, influencing, and negotiation skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.

Responsibilities

• Act as the dedicated clinical evaluation project manager, driving the establishment of a coherent clinical evidence strategy throughout the new product development cycle.
• Write/revise documents for regulatory submissions, pre-subs, annual reports, clinical evaluations, post-market clinical follow-up, summary of safety and clinical performance, post-market surveillance, and clinical studies to validate device safety and performance.
• Design compliant and sustainable literature search strategies, perform systematic reviews to capture and summarize published clinical data.
• Form and justify conclusions regarding the overall benefit-risk profile of medical devices, in collaboration with a medical expert and other stakeholders, based on up-to-date US, European, and other regulatory requirements.
• Communicate and negotiate with regulators on clinical evidence requirements to ensure the successful acceptance of regulatory submissions.
• Analyze current medical and scientific trends in the clinical state of the art on a broad variety of specialized indications and techniques.
• Lead evidence communication in partnership with stakeholders (e.g., Marketing, Clinical Research, Reimbursement & Market Access) to ensure alignment with business priorities.
• Support clinical research activities by identifying gaps in knowledge and developing strategies for pre-clinical and clinical data collection.
• Support new product development projects by helping cross-functional teams develop intended use and indication for use statements, risk files, and product claims.
• Support sustainment projects to ensure continued product availability. Help translate clinical data into new claims for existing products.
• Review marketing collateral for accuracy of clinical information, product performance, and safety claims.
• Proactively recognize potential scheduling and resource conflicts for projects and provide recommendations to resolve.
• Independently resolve document content issues and questions from external and internal reviewers. Coordinate and manage the cross-functional review process and ensure timely approvals from all reviewers.

Preferred Qualifications

• Motivated self-starter with the ability to work with minimal supervision and make independent decisions when limited information is available.
• Strong planning and organizational skills, attention to detail, and the ability to adapt and adjust to changing priorities.
• Analytical and problem-solving capabilities with a strong technical aptitude, including the ability to draw insights from data quickly and to define executable actions.
• Ability to build strong relationships by fostering open communication, respect, and trust.
• Act with a customer service/stakeholder-focused approach.