Senior Director/Director of Regulatory Affairs

Job Description

This position is a hybrid role 3-4 days a week onsite at our Andover, MA location.

Position Summary

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!

Responsibilities

This position is responsible for, but not limited to, the following:

• 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
  
  

Management Responsibilities

• This position will have 1-2 direct reports
  
  

PHYSICAL ATTRIBUTES

• General Office Environment
  
  

Minimum Qualifications

• BS in Engineering, Life or Biological Sciences, or related field;
• 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
  
  

Preferred Qualifications

• MS or PhD preferred
  
  

Every Organ Wasted is a Life Not Saved.

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.

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $251,750.00-$314,050.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

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.