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.