Direct message the job poster from Arevna We're looking for a proactive and experienced leader to take ownership of Quality Management and Regulatory Affairs within a dynamic, fast-paced MedTech environment. This is a fully on-site position requiring close collaboration with R&D, Manufacturing, and Customer Service teams to ensure the consistent delivery of safe, high-quality medical devices. The role is instrumental in driving both regulatory compliance and operational excellence. Key Responsibilities Lead and continuously enhance the company’s QMS, ensuring alignment with FDA, CE, ISO 13485, and other applicable regulatory standards Spearhead 510(k) submissions, CE marking processes, and support for external audits and inspections Oversee CAPA management, internal audits, complaints handling, document control, and employee training programs Promote a company-wide culture of compliance, accountability, and quality-first thinking Deliver transparent, data-driven reports and recommendations to senior leadership on quality system performance What We’re Looking For Bachelor's degree in a relevant technical or life sciences field Minimum of 6-7 years’ experience in quality and regulatory roles within Class II -III Medical devices Strong understanding of FDA QSR, ISO 13485, CE Marking, and 510(k) submissions Proven ability to lead cross-functional initiatives in a growth-oriented or entrepreneurial environment Excellent written and verbal communication skills, with a hands-on approach to problem-solving What You’ll Gain Join a purpose-driven team that’s advancing medical technology and improving patient outcomes. You'll be empowered to shape regulatory strategy and build a quality culture from the ground up with the backing of a passionate leadership team. The company offers a competitive compensation package, PTO, holidays, 401(k) with match, tuition reimbursement, and full health benefits including Medical, Dental, Vision, Life, and Disability coverage. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Quality Assurance, Engineering, and Manufacturing Industries Manufacturing, Medical Equipment Manufacturing, and Electrical Equipment Manufacturing Referrals increase your chances of interviewing at Arevna by 2x Get notified about new Director of Quality Assurance jobs in Orlando, FL . Director of Regulatory Affairs & Quality Assurance Director Quality Services Baptist Shelby Hospital Director of Training - Service Excellence Manager of Food Safety and Quality Assurance (Hybrid- Orlando,FL) Psychiatrist, Assistant Medical Director Registered Nurse (RN) - Intermediate Care Facility Licensed Practical Nurse (LPN) - Intermediate Care Facility Licensed Practical Nurse (LPN) - Part-time/On-call (PRN) Quality Manager in Projects (QMiP) - (9am-5pm) Clinical Practice Sup (OHMG) - Orlando Health - Full Time Fisheries Business Class Lead – Fisheries Facilities Design We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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