Specialist, Regulatory Affairs

TransMedics, Inc.; Andover (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

TransMedics, Inc. is seeking a Regulatory Affairs Specialist at our Andover, MA headquarters to lead regulatory submissions for complex Class III devices.

The role requires collaboration with Quality and Engineering teams and active involvement in FDA and EU regulatory processes. The ideal candidate has 3+ years in medical device regulation, strong communication skills, and the ability to manage multiple regulatory projects in a fast-paced environment.

Qualifications

• 3+ years regulatory experience in medical devices.
• Class III submissions experience preferred but not required.
• Ability to communicate ideas clearly, effectively, both oral and written.
• Independently determine methods and procedures with strong analytical skills.
• Detail oriented with strong organizational skills.

Responsibilities

• Prepare and maintain regulatory submissions and registrations for complex Class III devices in US and international markets.
• Maintain documentation and manage projects to meet regulatory requirements.
• Assist with international regulatory documents including EU Technical Files and EU MDR.
• Assist with vigilance reporting in US and worldwide.
• Serve as liaison with Quality and Engineering; support FDA and EU regulations.
• Participate in audits with FDA, Notified Bodies and internal teams as required.
• Manage multiple projects and prioritize tasks to meet schedules.
• Keep current knowledge of domestic and international regulations, guidelines and standards.
• Create or revise procedures to improve operations with changing regulatory requirements.

Skills

Regulatory submissions

Medical device regulatory

Communication skills

Project management

Attention to detail

Education

Bachelor’s in Engineering, Life or Biological Sciences

Master’s Degree a plus

Job description

POSITION SUMMARY

Due to rapid growth, we are currently looking for a Specialist, 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 TASK AND DUTIES INCLUDE

Prepare and maintain regulatory submissions and registrations of complex Class III devices in the US and in international markets Maintain documentation and perform project management tasks to support compliance with applicable regulatory requirements in the US and worldwide. Assist with the preparation of 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 Participate and provide support for FDA, Notified Body and internal audits as required Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules. Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements as needed

BACKGROUND AND QUALIFICATIONS

3+ years regulatory experience in the medical device industry with a proven record of successful regulatory submissions (Class III experience preferred but not required) Ability to communicate ideas and information clearly, effectively and frequently (oral and written) Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results Ability to utilize effective analytical and decision making skills Ability to act independently to determine methods and procedures Must be detail oriented with strong organizational skills Must have strong interpersonal skills with willingness to be held accountable for deliverables Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities

EDUCATION

Bachelor’s in Engineering, Life or Biological Sciences, or related field, Master’s Degree a plus

Every Organ Wasted is a Life Not Saved.

TransMedics, Inc. Overview

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. www.TransMedics.com #LI-Hybrid

Employee Benefit:

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental Vision Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

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)

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.