Regulatory Affairs Specialist, Medical Devices (US & Intl)

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

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.