Staff Clinical Evaluation Specialist (Remote)

Work Flexibility: Remote or Hybrid or Onsite

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

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.

What you will do

• 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 regulated industry required; preferably with medical devices.
• A minimum of 2 years in a Regulatory Affairs role required.
• Experience in scientific writing, performing systematic reviews, analyzing published literature, and statistical methods (may be in the form of peer-reviewed publications).

Preferred

• Strong interest in medical science, clinical research, and scientific communication.
• Demonstrated project management and organizational skills.
• Knowledge of FDA / MDR regulations for medical devices.
• Independent problem solver and ability to apply creative solutions

$105,100.00 - $172,300.00 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