Stryker Instruments is seeking a Senior C linical 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.
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.
Job Seekers, Please send resumes to ****@*****.*** Must Have Skills: Handson experience on endtoend implementation of Identity and Access Management using Forgerock OpenAM. Worked in at least 2 implementations. Good understanding of Forgerock OpenAM, OpenDS...
...including risk-adjusted survival, patient experience, level of nursing care and successfully returning patients home following... ...Schedules, coordinates, and reconciles all clinical in-person and telehealth appointments. Performs virtual and electronic patient registration...
Our award winning Annapolis based Interior Design firm is currently seeking Interior Designers. The ideal candidate will be proficient in... ...processes throughout a project, is a must. The candidate will assist designers with selections of fabrics, furniture, wallpaper and...
...s high regard for our employees. The Principal Specialist, Validation manages all phases of higher level, more complex validation project... ...and is responsible for assuring compliance of validated systems, process, equipment to current cGMP, FDA, EU, USDA, BIAH and BI...
...Job Overview: The Cardiac Cath Aide/Assistant functions under the direction of the department Director and Manager. The Cardiac Cath Aide/Assistant supports the department leadership, Registered Nurse (RN), and the technician population of the Cardiac Cath Lab....