Senior Clinical Evaluation Specialist (Remote)

Stryker Instruments is seeking a Senior Clinical Evaluation Specialist to be based remotely anywhere in the United States.

In this role you will collaborate with a variety of stakeholders to drive clinical strategy and enhance the impact of innovative healthcare technologies on patients and healthcare professionals.

Why come to Stryker? Dozens of Reasons To Love Stryker

Who we want

• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

• Contribute to the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle.

• Prepare 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).

• This role bears the operational and regulatory responsibility of individual clinical evaluation reports and may defend them in audit situations

• Supports the needs of other function (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.

• Support the Design of compliant and sustainable literature search strategies, performs systematic reviews to capture and summarize published clinical data.

• Analyze current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.

• Act as a Clinical Evaluation Project Manager for simple projects, 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).

• Identify, 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.

• Support in formulating 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 other country’s regulatory requirements.

• Supports in identifying 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

• Bachelor’s degree in a technical and/or scientific discipline required

• 2+ years industry experience in clinical, quality or regulatory affairs (Risk Management, Design quality, Post Market Safety etc.) required

• Working understanding of regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.

• Working knowledge of areas linked to clinical evaluation (e.g. regulatory requirements, data analysis, critical appraisal, etc.)

• Successful track record in managing complex deliverables independently, and managing simple projects.

• Ability to travel domestically and internationally, up to 20%.

Preferred

• Master's degree or Ph.D. in health-related field (RN, BSN, BPharm/MD/MPH) strongly preferred

• Experience in Scientific or Medical Writing, relevant academic or clinical research experience (PhD, Post-doc) strongly preferred

$75,300.00 - $156,900.00 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.