Position:       Regulatory Affairs Specialist

Report to:    Director of Regulatory Affairs

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 Regulatory Affairs Specialist to join our team.   If you are looking for a hands-on, 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:          

• Prepare and maintain regulatory submissions and registration of complex Class III devices in the US and in international markets
• Maintain documentation and perform project management tasks, including record keeping and tracking due dates for FDA and international regulatory submissions.
• Assist with the preparation of FDA applications and other international regulatory documents, including EU Technical Files and documentation related to EU MDR certification
• Assist with vigilance reporting in the US and around the world
• Serve as liaison with Quality and Engineering team members and provide support with FDA and EU regulations; participation in FDA and notified body audits as required
• Perform other TransMedics task and duties as required