Technical Associate

Join Mindray North America and help shape the future of patient care. Mindray is a global leader in medical technology, delivering advanced patient monitoring systems, anesthesia machines, ventilators, and ultrasound solutions trusted in hospitals and critical care environments worldwide. Unlike many larger competitors, Mindray combines cutting‑edge innovation with unmatched value, giving healthcare providers access to reliable, feature‑rich technology without compromise. Our culture is built on collaboration, integrity, and a drive to equip caregivers with the tools they need to deliver exceptional care. Fast facts about Mindray: Founded in 1991, with 14,000 employees worldwide 8 global R&D centers, investing ~10% of annual revenue into innovation North American headquarters in Mahwah, NJ, with 40+ international subsidiaries Job Summary The Manager, Regulatory Affairs oversees key regulatory functions that ensure compliance with U.S. FDA and Health Canada medical device regulations. This role manages complaint handling, medical device reporting (MDR/Vigilance), recalls, and related quality system activities. The position also provides cross‑functional regulatory support to project teams, marketing, quality, and service functions, while maintaining facility registrations, license renewals, and audit readiness. The Manager will supervise two Regulatory Affairs staff and act as the primary liaison for North American regulatory activities. What You’ll Do Manage complaint handling and MDR/Vigilance reporting processes, ensuring timely completion and full compliance with internal procedures and external regulatory requirements. Oversee the preparation, documentation, and resolution of complaint investigations, leveraging prior complaints, CAPA, and other technical data. Support internal and external audits by maintaining compliance documentation and coordinating corrective actions as needed. Lead or support regulatory activities related to product recalls, including drafting customer and agency notifications, tracking responses, and preparing close‑out reports. Provide regulatory guidance for new product introductions, marketing materials, and quality initiatives. Maintain FDA and Health Canada facility registrations, product listings, and distributor licenses. Collaborate with cross‑functional teams across Mindray North America (MRNA) and Mindray Shenzhen (MRSZ) to address regulatory questions and ensure alignment with global requirements. Train and mentor staff on complaint handling, regulatory best practices, and documentation standards. Monitor evolving regulatory trends in the U.S. and Canada and recommend policy or process improvements. What You’ll Bring Bachelor’s or advanced degree required. 8–10 years of experience in the medical device industry with strong working knowledge of FDA and Health Canada regulations. Direct experience managing FDA inspections, audits, and regulatory submissions. Proven leadership skills with the ability to oversee staff and manage multiple priorities in a dynamic environment. Exceptional written, analytical, and communication skills. Strong attention to detail and ability to work independently with minimal supervision. Proficiency in Microsoft Office and familiarity with quality management systems (QMS). Mindray North America offers a competitive compensation package and comprehensive benefits, including a 401(k) with company match, tuition reimbursement, paid time off, disability coverage, FSA/HSA options, and more—all within a dynamic, supportive, and collaborative work environment. Mindray North America is an Equal Opportunity Employer M/F/D/V. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status and will not be harassed or discriminated against. #J-18808-Ljbffr Mindray DS USA, Inc.