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) submissionsServe as contact person for regulatory submissions with FDA and prepare high quality response documents as neededRecruit, 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 productsDevelop and maintain processes and procedures for complaint review and Medical Device reportingServe as regulatory lead for FDA inspections for QSR and BIMOEstablish effective communication with executives and managers to ensure that company objectives and milestones are met, consistent with regulatory requirementsEnhance 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 proceduresPerform 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 prioritiesMust 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.