Specialist, Regulatory Affairs

TransMedics, Inc.•Andover, MA

11d•Onsite

About The Position

TransMedics 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, including preparation and maintenance of regulatory submissions and registrations, EU Technical Files, EU MDR certification documentation, and vigilance reporting. The Specialist works with Quality and Engineering colleagues, supports regulatory audits, manages multiple projects and maintains current knowledge of applicable regulations, guidance and standards. The position is part of a fast-paced, entrepreneurial medical technology company focused on expanding access to viable donor organs and improving transplant therapy.

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.
Strong attention to detail and organizational skills.
Strong interpersonal skills and willingness to be accountable for deliverables.
Proven ability to work in a fast-paced environment and adjust to changing priorities.
Bachelor’s degree in Engineering, Life Sciences, Biological Sciences or a related field.

Nice To Haves

Class III medical device regulatory experience.
Master’s degree.

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 around the world.
Serve as a liaison with Quality and Engineering team members and provide support regarding FDA and EU regulations.
Participate in and provide support for FDA, Notified Body and internal audits as required.
Manage multiple projects and prioritize daily 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 a Health Reimbursement Account through Blue Cross/Blue Shield of MA
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