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.

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.

Regulatory Affairs Specialist

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