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, thrive on challenges, and are interested in furthering your career, we want to talk to you!

Essential Job Duties and Responsibilities

• Develop and implement strategies and tactics to obtain FDA and international regulatory approvals of Class III marketing applications and clinical trial applications in the U.S. and globally.
• Prepare regulatory submissions for the FDA, including PMA and IDE applications, supplements, reports, and 510(k) submissions.
• Serve as the contact person for regulatory submissions with FDA and prepare high-quality response documents as needed.
• Recruit, manage, and mentor junior Regulatory Affairs (RA) staff members to form a high-performance RA team that can efficiently manage and complete regulatory projects in the U.S. and internationally.
• Work with Quality, Operations, and Sustaining Engineering teams on changes to products and manufacturing processes and serve as the regulatory lead in devising efficient strategies to ensure compliance with U.S. requirements.
• Collaborate 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 the regulatory lead for FDA inspections for QSR and BIMO.
• Establish effective communication with executives and managers to ensure 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, ensuring compliance through company policies and procedures.
• Perform other TransMedics tasks and duties as required.

Background and Qualifications

• Minimum 10+ years of regulatory experience in the medical device industry. Experience with Class III medical devices required.
• Minimum 5 years of management experience required.
• Solid experience and proven track record in successful FDA submissions, including IDE and PMA applications, supplements, and reports.
• Proven ability to exercise independent judgment and drive regulatory projects to successful completion.
• Must be a hands-on leader with demonstrated organizational skills and the ability to work in a fast-paced, dynamic environment with changing priorities.
• Strong interpersonal skills and the ability to communicate ideas and information clearly, effectively, and frequently (both oral and written).
• Proven analytical and decision-making skills.

Education

• BS in Engineering, Life or Biological Sciences, or a 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.

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