Regulatory Affairs Specialist

HemostasisLLC • Saint Paul, MN, US • published 2026-09-22 23:43:00.305190

Description

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, wound healing technologies, and advanced medical devices for use in the healthcare industry. We are currently seeking a Regulatory Affairs Specialist that will be able to ensure compliance with regulations. **Responsibilities Include:** * Communicate with regulatory agencies regarding pre\-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow\-up of submissions under review. * Provide technical review of data or reports that will be incorporated into regulatory submissions. * Analyze validation test data to determine whether systems or processes have met validation criteria. * Study product characteristics or customer requirements and confer with management to determine validation objectives and standards. * Identify deviations from established product or process standards and provide recommendations for resolving deviations. * Develop validation master plans, process flow diagrams, test cases, and standard operating procedures. * Create, populate and maintain the database for tracking validation activities, test results and validation systems. * Pr...

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