Are you passionate about quality assurance and regulatory compliance in the medical device industry? Terumo Aortic is seeking a Standards Compliance Quality Specialist to join our External Quality team.

Key Responsibilities

• Monitor and evaluate new and revised standards/regulations for impact on products and QMS processes.
• Review updates to regulations and standards to ensure ongoing compliance of products and systems.
• Maintain compliance throughout the product lifecycle—from design and development to manufacturing and post-market surveillance.
• Identify gaps in regulations/standards and coordinate actions with relevant departments.
• Facilitate closure of compliance actions and monitor status via trending.
• Present status updates during meetings and highlight risks to management.
• Ensure all processes and procedures meet regulatory standards (EU MDR, ISO 13485, 21 CFR Part 820/QMSR, Japan MHLW Ordinance 169, and other country-specific regulations).
• Collaborate with R&D, manufacturing, and regulatory teams to integrate compliance into product design and development.
• Provide training and guidance on regulations/standards and compliance best practices.
• Conduct internal audits and support external audits as a subject matter expert (e.g., FDA inspections, Notified Body audits, Customer audits).
• Generate and maintain trending data for the Standards Management process and publish as part of QMS governance forums.
• Update QMS documentation with respect to key changes for standards, working closely with cross-functional SMEs.

What We’re Looking For

• Degree in Science/Engineering or equivalent background.
• Class III medical device knowledge (desirable).
• In-depth knowledge of medical device regulations and standards (FDA, ISO, EU MDR).
• Experience with QMS tools and document control systems.
• Strong analytical, problem-solving, and communication skills.
• Certification such as CQE, CQA, or Lead Auditor (ISO 13485) is highly desirable.
• Ability to work independently and influence change with objective information and well-structured communications.
• Competence in IT technology (Microsoft Office and QA systems).