Regulatory Affairs Specialist

Terumo Medical Corporation

Regulatory Affairs Specialist overseeing compliance with regulatory requirements and strategies for medical devices. Preparing necessary documentation for approvals and acting as liaison with regulatory agencies.

Posted 6/5/2026full-timeSomerset • New Jersey • 🇺🇸 United StatesJunior💰 $61,440 - $84,480 per yearWebsite

About the role

Key responsibilities & impact

This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects
define information and actions necessary to meet requirements.
prepare documents and/or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide.
Serve as a liaison between Regulatory Agencies and Terumo Medical Corporation.
Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution.
Participates on product design teams and verifies compliance with design control requirements and procedures.
Maintain documentation and a historical record for projects and provide management with updated product status.
Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels with guidance.
Assist external customers by supplying materials and documentation for US and International product registrations as well as certification of appropriate US commercialization status.

Requirements

What you’ll need

Requires a minimum of a 4-year degree in engineering, life sciences, or similar discipline
one year of relevant experience or combination of equivalent education, background, experience and training
Experience in a medical device quality assurance environment preferred
Experience with 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances preferred.
Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards preferred.

Benefits

Comp & perks

annual bonus
paid vacation
paid holidays
health, dental and vision benefits
401(k), with matching contributions
tax advantage savings accounts
legal plan
voluntary life and AD&D insurance
voluntary long-term disability
short term disability
critical illness and accident insurance
parental leave
personal leave
tuition reimbursement
travel assistance
employee assistance program

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory requirementsdocument preparationdata analysiscompliance verificationproduct registration510(k) submissionsIDE submissionsPMA submissionsFDA requirementsISO 14971

Soft Skills

communicationinterdepartmental collaborationliaison skillsorganizational skillsguidance provision