Regulatory Software Project Specialist (34467)

Who We Are

At KLS Martin, we offer a unique opportunity to contribute to the success of a dynamic and thriving company whose products are used daily across the world to help surgical patients.  

The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. Surgical innovation is our passion, and we are constantly working with surgeons to improve surgical care for their patients. Our product portfolio includes titanium and resorbable implants for reconstruction, innovative distraction devices to stimulate bone lengthening, over 4,000 surgical instruments, and other surgical products designed specifically for CMF and cardiothoracic surgeons.  

KLS Martin is an innovative leader in the treatment of CMF deformities and trauma cases. We use Individual Patient Solutions (IPS) by using our proprietary IPS products where CT scans are used to custom design implants that are created specifically for that individual patient.  This technology allows our surgeons to provide the best-in-class treatment for their patients. 

KLS Martin Guiding Principles 

• Established, Privately Held Business Group – Responsive to customers, not shareholders. KLS Martin has manufactured medical products since 1896, and we have sold our products in the United States under the KLS name since 1993. We have always been, and always will be, privately owned.
• Patient Focus – We design products with the patient in mind – CMF, Thoracic & Hand
• Product to Table – Integrated planning, design, manufacturing and distribution process
• Educational Partner – Our primary focus for support is on education
• Inventory Alliance – Inventory management is critical to patient treatment/outcome
• Surgical Innovation is Our Passion – More than just a tagline

What We Offer

• We provide full-time employees with a competitive benefits package, including 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

**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. 

Educational 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: 

  • Prefer advanced knowledge of MS Excel (including vLookup and Pivot Tables) 

  • 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 

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)

Physical Requirements 

• Sitting for extended periods 
• Extended periods viewing computer screen 
• Walking 
• Reading 
• Speaking 
• Hear/Listen
• Maintain regular, punctual attendance
• Writing

Hazards 

• Normal office environment 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

KLS Martin is a drug-free employer