Opportunity Description
Job Title: Regulatory Software Assurance SpecialistJob Description
The Regulatory Software Assurance Specialist administratively supports, governs, coordinates, and continuously improves software compliance activities across product development, production, and quality systems. This role ensures that software used in regulated environments meets FDA and global regulatory expectations through risk-based Computer Software Assurance (CSA) approaches and provides support for software regulatory submission projects. The specialist exercises discretion and independent judgment in matters related to the quality management system and adverse event considerations within a medical device environment.
Responsibilities
+ Maintain Computer Software Assurance (CSA) frameworks aligned with FDA guidance, ISO standards, and applicable medical device regulations.
+ Drive improvements to CSA documentation workflows, templates, and knowledge repositories to enhance consistency, eff...
The Regulatory Software Assurance Specialist administratively supports, governs, coordinates, and continuously improves software compliance activities across product development, production, and quality systems. This role ensures that software used in regulated environments meets FDA and global regulatory expectations through risk-based Computer Software Assurance (CSA) approaches and provides support for software regulatory submission projects. The specialist exercises discretion and independent judgment in matters related to the quality management system and adverse event considerations within a medical device environment.
Responsibilities
+ Maintain Computer Software Assurance (CSA) frameworks aligned with FDA guidance, ISO standards, and applicable medical device regulations.
+ Drive improvements to CSA documentation workflows, templates, and knowledge repositories to enhance consistency, eff...
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