Senior Research Scientist

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Position Overview

Under the supervision of the Manager, Stability, Verification and Validation (Handheld), the Research Professional oversees verification and validation activities for both new and on-market products in support of regulatory submissions and post-market documentation.

The role operates at a scientist level and requires a high degree of independence and technical expertise.

Responsibilities include technical development and experimental screening, as well as the design, execution, and interpretation of complex studies with minimal supervision.

The Senior Research Scientist engages and collaborates with cross-functional stakeholders, including Regulatory Affairs, Clinical Affairs, Marketing, Product Health, Research and Development, and Stability, Verification and Validation.

Responsibilities


* Manages planning and execution activities for internal validation, preliminary evaluations, continuous improvement initiatives, product portfolio life-cycle management, and post-market evaluations.

This includes protocol development and study design, document management.


* Performs data acquisition for a broad range of in-house and field verification and validation studies, including but not limited to Alpha studies, method comparison, precision, limit of quantification, and interference testing.


* Compiles, analyzes, and clinically interprets study data, and prepares technical reports and support regulatory summaries.


* Manages investigational product supply logistics, working closely with Export Control and Customs specialists as well as Shipping and Receiving to ensure timely delivery to collaboration sites and to resolve logistical issues as needed.


* Contributes to the development of customer-facing collateral, including case studies, proof points, white papers, and customer bulletins, in close collaboration with R&D, Quality, Regulatory, and Marketing.


* Supports preparation of regulatory submissions, including but not limited to FDA Pre-Submissions, FDA 510(k) submissions, IVDR submissions, and CLIA Waiver applications, as required.

Required Knowledge, Skills, Education, and Experience


* Master's or PhD's degree in a relevant technical discipline, or an equivalent combination of education and applicable technical experience.


* Minimum of 8 years of clinical research experience in the medical device, healthcare, or pharmaceutical industry.


* Demonstrated expertise in point-of-care blood gas and chemistry analysis within the medical diagnostics or clinical laboratory environment.


* Proven ability to interface ...