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New · posted Oct 30

TransMedics · Medical Devices

Specialist, Regulatory Affairs

  • Andover, MA
  • Hybrid
  • Full-time
  • Associate & Specialist
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PayNot published
EmploymentFull-time
LocationAndover, MA
LevelAssociate & Specialist
FunctionRegulatory Affairs
DeadlineOpen until filled

The role

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!

What you need

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. 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

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

Skills named in this posting

What you'll do

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

Pay

TransMedics didn't publish pay for this role

See what similar roles pay on Regulatory Jobs, or try the salary calculator.

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

Where you'll work

Andover, MAHybridOpen in Maps (opens in a new tab)

More jobs in Andover, MA
Equal opportunity, accessibility and legal noticesTransMedics's statements, word for word

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.

Job intelligence

The context around this role

Live data · October 30, 2026

Salary intelligence

How the pay compares

Associate & Specialist roles in the US36 roles publishing pay

Middle half $84,000 to $95,500, median $92,000
Annual base pay
Annual base payLowMedianHigh
All US$84,000$92,000$95,500

Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 30, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Affairs

The general path across 313 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not TransMedics's own promotion track.

  1. This role

    Associate & Specialist

    Often: Regulatory Affairs Specialist · Summer 2027 Internship

    $92K median46 open

  2. Next step

    Senior & Principal

    Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

    $141K median71 open

  3. Later

    Manager

    Often: Manager, Regulatory Affairs · Regulatory Affairs Manager

    $161K median70 open

  4. Later

    Director

    Often: Director, Regulatory Affairs · Senior Director, Regulatory Affairs

    $235K median109 open

  5. Later

    VP & Executive

    Often: Global Head of Injectable Aesthetics Regulatory Strategy · Global Head of Regulatory Affairs, Roche Diagnostics

    $323K median17 open

Career resources on Regulatory Affairs

Skills DNA

What this role leans on

How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 4 linesLab testing and methods: 3 linesDocumentation and SOPs: 6 linesRegulatory submissions: 3 linesCollaboration and leadership: 3 linesGMPLab testingDocumentationSubmissionsTeamwork
  • Documentation and SOPs6
  • GMP and compliance4
  • Lab testing and methods3
  • Regulatory submissions3
  • Collaboration and leadership3

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

TransMedics on Regulatory Jobs

6
Open roles
6
Distinct roles
1
Locations

By discipline

  • Quality5 83%
  • Regulatory1 17%

By level

  • Associate & Specialist3 50%
  • Senior & Principal2 33%
  • Manager1 17%
See all 6 TransMedics roles

More roles at TransMedics

All 6 TransMedics roles

Similar Regulatory Affairs roles elsewhere

Specialist, Regulatory Affairs at TransMedics

Open until filled.

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