Staff Clinical Evaluation Specialist (Remote)

Work Flexibility: Remote or Hybrid or Onsite

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com

We are currently seeking a Staff Clinical Evaluation Specialist join the Clinical Affairs, Joint Replacement Division, with the flexibility of hybrid or remote work arrangements.

Who We Want

• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. 
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

What you will do

In your role as a Staff Clinical Evaluation Specialist on the Clinical Affairs team, you will lead the process of planning, writing, and updating Clinical Evaluation documentation (e.g., CERs, CEPs, SSCPs, PMCFPs, PMCFRs) to bring State of the Art medical devices to market. You will act as the subject matter expert that drives Clinical Evidence generation. You will conduct thorough research on the subject device, perform systematic reviews of published literature, extract data, interpret trends, and communicate scientific findings to support regulatory body submissions for diverse geographies. You will apply your project management skills to compile the body of Clinical Evidence on which you, in collaboration with other stakeholders, will reach a scientific conclusion on the safety and performance of our products throughout its entire lifecycle. Your valuable work will help deliver industry-leading Joint Replacement products to the customer and rebuild lives of patients across the globe.

• Prepares clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCFRs, PMCFPs, SSCPs).
• Supports the needs of other business units (e.g., R&D, Marketing, Clinical Research) regarding communication of clinical data in the form of peer-reviewed publications, white papers, 1-pagers, clinical summaries, posters, and slide decks/presentations.
• Designs compliant and sustainable literature search strategies, performs systematic reviews to capture and summarize published clinical data, and analyzes current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.
• Acts as the dedicated Clinical Evaluation Project Manager, driving the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle, and fosters alignment with adjacent processes (marketing strategy and claims, regulatory strategy, clinical research strategy, preclinical testing strategy).
• Identifies, appraises, and analyzes 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.
• Forms a conclusion on the overall benefit-risk profile of the subject device, in collaboration with a Medical Expert and other stakeholders, based on up-to-date US, European, and Australian regulatory requirements.
• Identifies unanswered questions and residual risks in the Clinical Evidence and designs Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions.

What you need

• A minimum of a Bachelor’s Degree (B.S. or B.A.) in Life Sciences, Engineering, or similar concentration required.
• A minimum of 4 years of experience in an FDA or highly regula