Regulatory Software Project Specialist KLS Martin Group - 2.9 Jacksonville, FL Job Details Full-time $75,000 - $85,000 a year 17 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Flexible schedule Life insurance Referral program Qualifications Content creation for technical audiences Interpersonal skills Customer service ISO standards
FDA 21 CFR
Part 11 Bachelor's degree Attention to detail Software documentation Organizational skills Biomedical regulatory compliance Productivity software Technical writing within technology Full Job Description Regulatory Software Project Specialist
- This will be a local REMOTE position However, you must reside within 50 miles of Jacksonville, FL, due to the
- occasional in-office responsibilities.
- Job Summary 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. Essential Functions, Duties, and 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.
Education and Experience 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: o Prefer advanced knowledge of MS Excel (including vLookup and Pivot Tables) o Prefer advanced knowledge of MS PowerPoint Knowledge, Skills, and Abilities 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
Pay:
$75,000.00 - $85,000.00 per year
Benefits:
401(k) Dental insurance Flexible schedule Health insurance Life insurance Paid time off Referral program Vision insurance
Work Location:
Hybrid remote in Jacksonville, FL 32246
