Senior Director/Director of Regulatory Affairs

Job Description: TransMedics’ pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage, by preserving donor organs in a living, functional state during transport. Unlike traditional cold-storage methods, the OCS Systems feature warm, normothermic perfusion, and provide the means to monitor organ health so that transplant patients can experience better outcomes. We are laser focused on transforming the standard of care – increasing organ utilization and transplant volumes, improving patient outcomes, and reducing transplant costs, resulting in more transplantable organs being made available so that more patients can benefit from life-saving transplant procedures. Due to rapid growth, we are currently looking for a Senior Director/Director of Regulatory Affairs, based in our Andover, MA headquarters, to join us as we revolutionize this cutting-edge medical field. If you are looking for a forward-thinking and fast-paced entrepreneurial culture, you thrive on challenges and are interested in furthering your career, we want to talk to you! ESSENTIAL JOB DUTIES AND RESPONSIBILITIES INCLUDE: Develop and implement strategies and tactics to obtain FDA and international regulatory approvals of Class III marketing applications and clinical trial applications in the US and around the world. Prepare regulatory submissions for the FDA, including PMA and IDE applications, supplements and reports and 510(k) submissions Serve as contact person for regulatory submissions with FDA and prepare high quality response documents as needed Recruit, manage and mentor junior RA staff members to form a high-performance RA team that can efficiently manage and complete regulatory projects in the US and globally. Work with Quality, Operations and Sustaining Engineering teams on changes to products and manufacturing processes and serve as regulatory lead in devising efficient strategies to ensure compliance with US requirements Work with Product Development teams to provide regulatory strategy and submission preparation for new products Develop and maintain processes and procedures for complaint review and Medical Device reporting Serve as regulatory lead for FDA inspections for QSR and BIMO Establish effective communication with executives and managers to ensure that company objectives and milestones are met, consistent with regulatory requirements Enhance and sustain positive relationships with the FDA and other regulatory agencies Review and interpret regulatory rules as they relate to company procedures, clinical studies, engineering testing, and documentation and ensure that they are communicated through company policies and procedures Perform other TransMedics tasks and duties as required BACKGROUND AND QUALIFICATIONS: Minimum 10 years regulatory experience in the medical device industry. Experience with Class III medical devices required. Minimum of 5 years management experience required. Solid experience and proven track record in successful FDA submissions including IDE and PMA applications, supplements and reports. Proven track record of exercising independent judgment and driving regulatory projects to successful conclusion Must be a hands-on leader with demonstrated organizational skills and the ability to work in a fast paced, dynamic environment with changing priorities Must have strong interpersonal skills and ability to communicate ideas and information clearly, effectively and frequently (oral and written) Proven analytical and decision-making skills EDUCATION: BS in Engineering, Life or Biological Sciences, or related field; MS or PhD preferred TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.