The Opportunity: EU MDR Expedition We are looking for an experienced, hands-on Regulatory & Quality Manager to take ownership of critical strategic milestones. Over the next 12 months, your primary mission would be to transition of our FDA-based technical files into full EU MDR-compliant documentation to unlock CE marking across our product portfolio. Fair warning: This is a hands-on execution role, not a purely advisory one. You’ll be steering the ship and rowing at the same time. Alongside the MDR marathon, you’ll drive continuous improvement across our Quality Management System (QMS) and product quality control processes, keeping our operational engine running like a Swiss watch. We will expand into many new countries, each with its own regulatory questions, and you will navigate the improvement and implementation of our processes. What You’ll Actually Do (Key Responsibilities) Lead the charge in converting FDA-based technical files into EU MDR-compliant masterpieces for CE marking. Maintain and level-up our QMS in strict alignment with ISO 13485, FDA 21 CFR Part 820/803, and EU MDR. Turn CAPA, non-conformances, and audits from "bureaucratic chores" into strategic tools for product quality improvement. Figure out new innovative ways to automate and redesign our regulatory and RAQA procedures. Manage risk management activities in total alignment with ISO, MDR, and MDSAP. Work closely with engineering, manufacturing, and clinical teams on design controls, quality assurance, labeling, and post-market surveillance. Act as our primary, highly articulate point of contact for notified bodies, regulatory authorities, and international partners. What We’re Looking For Proven, hands-on experience with ISO 13485, FDA regulations, and EU MDR. (All three are essential; we aren't looking for trainees here) Real-world experience preparing EU MDR technical documentation or successfully transitioning legacy files. A solid understanding of ISO 13485, design controls, and post-market surveillance. The ability to write detailed technical documentation and explain complex regulatory hurdles to engineers Attention to detail and an enjoyment for being pedantic. Bonus Points: RAC/CQE certifications, or a handy working knowledge of SAHPRA / the South African regulatory landscape. Why Join Ortho-Design? This is an opportunity to take ownership of a major international regulatory programme within a rapidly scaling MedTech company. You’ll work alongside a passionate team, collaborate with globally recognised surgeons, and play a direct role in bringing innovative orthopedic technologies to markets worldwide. #J-18808-Ljbffr