Regulatory Affairs Associate

US ARKRAY INC•Plano, TX

2d•Onsite

About The Position

This role provides hands-on support for on-site clinical studies, including training clinical site staff, monitoring and data verification, troubleshooting instrument issues, and preparing study materials. The position involves travel to clinical study sites for setup, training, monitoring, and other study support. Additionally, it includes performing in-house evaluative/bench studies of ARKRAY products, new products, and competitive products to support regulatory approval and institutional knowledge. The role ensures scientific work, data generation, and project activities comply with applicable requirements and standards, recommending and applying appropriate scientific approaches. Responsibilities also include reviewing and assessing complaint investigation results, acting as Principal Investigator for in-house clinical studies, and performing digital urine sediment analysis. Adherence to Quality Control policies and support for Sales and Marketing by addressing FDA compliance-related questions are key aspects. The role further supports the evaluation/validation of digital or image-based diagnostic systems, participates in pre-/post-market regulatory activities, and supports product launch regulatory work. Quality system activities, complaint handling, and post-market activities are also part of the scope. General duties may include coordinating office activities and processing company mail for the Miami facility.

Requirements

Bachelor’s degree in Biology, Biochemistry, Chemistry, or related discipline.
3–5 years of experience in a medical laboratory and/or medical device industry.
Urinalysis IVD instruments for laboratory and manual microscopy experience (hematology/POC/consumer use preferred).
Proficiency in Microsoft Office (Word, Adobe, Excel, PowerPoint).
Ability to travel domestically and internationally.
Urinalysis product use and manual microscopy experience.

Nice To Haves

Clinical study management experience preferred.
Florida Medical Technologist license and applicable certification (ASCP/AMT as outlined in job description).

Responsibilities

Provide hands-on support for on-site clinical studies, including training clinical site staff, monitoring and data verification, troubleshooting instrument issues, and preparing study materials (reagents/equipment).
Travel to clinical study sites for setup, training, monitoring, and other study support as needed.
Perform in-house evaluative/bench studies of ARKRAY products, new products, and competitive products for institutional knowledge and/or to support regulatory approval.
Ensure scientific work, data generation, and project activities comply with applicable requirements and standards; recommend and apply appropriate scientific approaches for product updates and future work.
Review and assess complaint investigation results related to Blood Glucose Monitoring Systems.
Act as Principal Investigator for ARKRAY in-house clinical studies as assigned, including maintaining required documentation and certifications for IRB review if needed.
Perform digital urine sediment analysis using image-based microscopy systems; review, classify, and verify cells, casts, crystals, and microorganisms.
Adhere to Quality Control policies, including documentation of QC activities, calibrations, maintenance, and performance monitoring.
Support Sales and Marketing by helping address FDA compliance-related questions or concerns from customers.
Support evaluation/validation of digital or image-based diagnostic systems; provide feedback on image classification performance, discrepancies, and limitations to support data integrity.
Participate in pre-/post-market regulatory activities as assigned (labeling review/approval, FDA submission support, consultant coordination, and 510(k) support with R&D).
Support product launch regulatory work such as Regulatory Master Plans, labeling program coordination, UDI/GUDID activities, facility registrations/device listings, import inspections/holds, and related documentation support.
Support quality system activities as assigned, including audit support, validation/change control support, supplier activities, internal audit participation, and QMS compliance activities (FDA QMSR, ISO 13485, OSHA).
Support complaint handling and post-market activities as assigned (risk reviews, recalls/field actions support, complaint meeting support, MDR support, vendor reporting, and daily call data review as applicable).
Perform other reasonably related duties as assigned by management.