Job Description

3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. We’re seeking a proactive, experienced regulatory and quality leader to manage and enhance our Quality Management System (QMS) and global regulatory activities. This on-site role (no remote) is critical to ensuring full compliance with FDA , CE , ISO 13485 , and other applicable standards while supporting fast-paced product innovation and business growth. You’ll collaborate cross-functionally with R&D, Manufacturing, and Customer Service to deliver safe, high-quality Class II medical devices to global markets. Key Responsibilities: Lead and continuously improve Omega’s QMS in alignment with FDA QSR, ISO 13485, and EU MDR requirements to ensure regulatory compliance and product excellence Prepare and manage Class II 510(k) submissions, technical documentation for CE marking under EU MDR, and other international submissions as needed Serve as the primary regulatory liaison during FDA inspections, notified body audits, and internal/external quality audits Oversee CAPA, complaints, internal audits, employee training, and document control processes Ensure timely reporting and escalation of adverse events and field actions in compliance with post-market surveillance requirements Support design control and risk management activities to ensure products meet applicable regulatory requirements throughout the development lifecycle Promote a culture of quality, accountability, and continuous improvement across the organization Provide clear, data-driven reports on QMS performance, audit readiness, and regulatory metrics to executive leadership Requirements: Bachelor’s degree in engineering, life sciences, or a related technical field 5+ years of hands-on regulatory and quality assurance experience with Class II medical devices in both U.S. (510(k)) and EU (MDD/MDR CE Marking) markets Strong understanding of FDA GMP/QSR , ISO 13485 , EU MDR , 21 CFR Part 820 , and IEC 62304 (preferred for devices with software components) Demonstrated success in authoring and submitting 510(k)s , preparing EU technical documentation , and managing regulatory interactions with FDA and EU notified bodies Proven leadership in managing quality systems in a medical device manufacturing environment Excellent cross-functional collaboration, communication, and organizational skills Exceptional attention to detail, technical writing, and problem-solving abilities Seniority level Seniority level Director Employment type Employment type Contract Job function Job function Consulting Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at ALKU by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Director of Regulatory Affairs jobs in Greater Orlando . DeLand, FL $155,000.00-$180,000.00 2 weeks ago Director of Regulatory Affairs & Quality Assurance Winter Park, FL $175,000.00-$200,000.00 1 week ago DeLand, FL $150,000.00-$195,000.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr ALKU

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