Regulatory Software Project Specialist (34467)

KLS MARTIN LP • Jacksonville, FL

3d • Hybrid

About The Position

Administratively assist with support, governance, coordination, and continuous improvement of 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. Exercises discretion and independent judgement related, but not limited to, adverse event and the quality management system.

Requirements

• 4-year degree in Engineering, Life Sciences, or Information Technology preferred
• 2-4 years of experience in CSA, CSV, or software validation in a regulated industry
• Knowledge of FDA 21 CFR Part 11, ISO 13485, and CSA methodologies
• Excellent technical documentation and communication skills
• Proficient user of Microsoft Office applications
• Prefer advanced knowledge of MS Excel (including vLookup and Pivot Tables)
• Prefer advanced knowledge of MS PowerPoint
• Strong interpersonal skills with the ability to effectively communicate (written and verbal) at all levels internally as well as externally
• Utmost respect for confidentiality
• Extreme attention-to-detail
• Excellent organizational skills
• Ability to properly manage time and multiple priorities
• Strong ability for problem solving, adaptability, and flexibility
• High level of customer service with a positive attitude
• Ability to retrieve and interpret documentation
• Ability to work in a team setting and independently under minimum supervision
• Exercises good judgment
• Skill Requirements Typing/computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Verify data and information
• Organize and prioritize information/tasks
• Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
• Verbal communication
• Written communication
• Public speaking/group presentations
• Research, analyze and interpret information
• Investigate, evaluate, recommend action
• Basic mathematical concepts (e.g. add, subtract)
• Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)

Responsibilities

• Maintain CSA frameworks aligned with FDA guidance and ISO standards.
• Drive improvements to CSA documentation workflows, templates, and knowledge repositories to enhance consistency and efficiency.
• Support risk assessment activities by gathering data and participating in team discussions.
• Author and review validation/assurance documentation.
• Collaborate with cross-functional teams to help implement and monitor compliance of quality and production software systems.
• Contribute to cross-functional process optimization initiatives, using CSA principles to streamline validation, change control, and system implementation practices.
• Contribute to the preparation of validation documents such as test protocols, user requirements, and traceability matrices under guidance.
• Support compliance activities for software regulatory submission projects, including providing technical support, assisting with requirements gathering, and compiling regulatory documentation under guidance.
• Stay informed on regulatory updates and industry trends through training and team briefings.

Benefits

• paid parental leave
• In-house training and professional development opportunities
• A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level