Specialist, Regulatory Affairs

TransMedics • Andover, MA

6d • Hybrid

About The Position

TransMedics, Inc. is seeking a Specialist, Regulatory Affairs, based at its Andover, Massachusetts headquarters. The role supports regulatory compliance for complex Class III medical devices in the United States and international markets. The Specialist prepares and maintains regulatory submissions and registrations, supports international regulatory documentation and vigilance reporting, and collaborates with Quality and Engineering teams. The position also supports audits, manages multiple projects, and maintains current knowledge of applicable regulations, guidelines, and standards. TransMedics describes itself as a commercial-stage medical technology company working to expand access to viable donor organs and improve transplant care and outcomes.

Requirements

• At least 3 years of regulatory experience in the medical device industry, with a proven record of successful regulatory submissions.
• Ability to communicate ideas and information clearly, effectively, and frequently, both orally and in writing.
• Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results.
• Effective analytical and decision-making skills.
• Ability to act independently to determine methods and procedures.
• Detail-oriented, with strong organizational skills.
• Strong interpersonal skills and willingness to be held accountable for deliverables.
• Proven ability to work in a fast-paced environment and adjust to changing priorities.
• Bachelor’s degree in Engineering, Life or Biological Sciences, or a related field.

Nice To Haves

• Class III medical device experience preferred.
• Master’s degree is a plus.

Responsibilities

• Prepare and maintain regulatory submissions and registrations for complex Class III devices in the United States and international markets.
• Maintain documentation and perform project management tasks to support compliance with applicable U.S. and worldwide regulatory requirements.
• Assist with preparing international regulatory documents, including EU Technical Files and documentation related to EU MDR certification.
• Assist with vigilance reporting in the United States and worldwide.
• Serve as a liaison with Quality and Engineering team members and provide support regarding FDA and EU regulations.
• Participate in and support FDA, Notified Body, and internal audits as required.
• Manage multiple projects and prioritize tasks to meet project schedules.
• Maintain current knowledge of domestic and international regulations, guidelines, and standards.
• Create or revise departmental procedures to improve operations or reflect changing regulatory requirements.

Benefits

• Medical insurance with Health Reimbursement Account through Blue Cross/Blue Shield of Massachusetts
• Dental insurance
• Vision insurance
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short-term disability
• Long-term disability
• 401(k) plan
• Pet insurance
• Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level