TransMedics, Inc. · 2 weeks ago
Senior Director/Director of Regulatory Affairs
Andover, MA
Full-time
Onsite
Director/Executive
10+ years expTransMedics, Inc. is a pioneering company focused on transforming the standard of care in organ transplantation. They are seeking a Senior Director/Director of Regulatory Affairs to lead strategies for obtaining regulatory approvals and to manage a high-performance regulatory affairs team.
Health CareMedicalMedical DeviceService IndustryWellness
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 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
Qualification
Required
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
BS in Engineering, Life or Biological Sciences, or related field
Preferred
MS or PhD preferred
Company
TransMedics, Inc.
Every Organ Wasted is a Life Not Saved. TransMedics, Inc.
Founded in 1998Andover, Massachusetts, USA
501-1000 employees
H1B Sponsorship
TransMedics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (3)
2022 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$721.33MKey Investors
CIBC Innovation BankingAbrams CapitalTudor Investments
2023-05-08Post Ipo Debt· $400M
2022-09-15Post Ipo Debt· $60M
2020-04-24Post Ipo Debt· $2.2M
Leadership Team
Waleed Hassanein
President & CEO
Gerardo Hernandez
Chief Financial Officer
Recent News
2026-01-22
Boston Globe
2026-01-19
FX News Group
2026-01-16
Company data provided by crunchbase