Sr. Staff Clinical Evaluation Specialist

Work Flexibility: Remote

Stryker is hiring a Senior Staff Clinical Evaluation Specialist, this position is Remote, supporting our Instruments Division. Preference will be given to candidates in the Eastern and Central locations of the United States.

As a Senior Staff Clinical Evaluation Specialist, you will work closely with cross-functional teams (Marketing, Regulatory, Reimbursement & Market Access, Clinical Research, Quality) ensuring successful preparation of high-quality, submission-ready clinical documents to enable global market availability. This position requires working independently with minimal supervision.

What you will do

• Act as the dedicated clinical evaluation project manager, driving the establishment of a coherent clinical evidence strategy throughout the new product development cycle. Foster alignment with adjacent processes (e.g., marketing strategy and claims, regulatory strategy, clinical research strategy, preclinical testing strategy).
• 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. Identify, appraise, and analyze relevant clinical, post-market surveillance, marketing, and preclinical testing data to create comprehensive scientific reviews, which may include in-depth quantitative analyses, qualitative analyses, and risk management cross-checks. Synthesize information in clinical documents in a clear, concise, and scientifically accurate manner. Maintain documentation throughout the product lifecycle.
• 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. Translate complex scientific and technical information into accessible content for various audiences, including regulatory bodies and customers. Create publication plans supporting key products. Prepare documents like manuscripts, conference presentations/posters, white papers, and customer-facing promotional materials. Assist customers with manuscript/presentation preparation.
• 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. Identify and implement new strategies to enhance team efficiency.
• 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.

What you need

• 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.

Preferred

• 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.

• $100,500.00 - $165,600.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.