Standard Compliance Quality Specialist

Terumo Aortic; Scotland; On-site; GBP 40,000 - 60,000; Full time

Job summary

A medical device company in the United Kingdom is seeking a Standards Compliance Quality Specialist to join their External Quality team. The successful candidate will monitor and evaluate standards impacting product compliance and collaborate with various departments to integrate compliance into product design. They should possess a degree in Science or Engineering, strong analytical skills, and in-depth knowledge of FDA and ISO regulations. This role offers an opportunity to influence quality assurance in a dynamic regulatory environment.

Qualifications

• Degree in Science/Engineering or equivalent background required.
• Knowledge of Class III medical devices is desirable.
• In-depth knowledge of medical device regulations and standards required.

Responsibilities

• Monitor and evaluate new standards for product impact.
• Ensure ongoing compliance of products throughout lifecycle.
• Facilitate closure of compliance actions.

Skills

Analytical skills

Problem-solving skills

Communication skills

Knowledge of FDA regulations

Knowledge of ISO standards

Experience with QMS tools

Education

Degree in Science/Engineering

Tools

Microsoft Office

QA systems

Job description

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).