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BSI

Global standards and business improvement partner

Technical Specialist - IVD (In Vitro Diagnostic) - Medical Device Technical Expert

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRemote in ChinaNo salary listed

About the Job

Requirements

  • A bachelor's degree or higher in a discipline relevant to IVD medical device design, manufacture, and use, or an equivalent qualification.
  • At least four years of post-graduate experience in the design and development of IVD medical devices, including design control, risk management, and performance and/or clinical evaluation, primarily focused on IVD infectious diseases.
  • Knowledge of medical device regulations.
  • Awareness of certification business processes, application of quality management standards, and audits.

Responsibilities

  • Build, control, and manage a portfolio of medical device CE-marking schemes focused on the area of expertise.
  • Deliver technical reviews and scheme management in support of CE-marking schemes.
  • Provide medical device quality management system assessment and device expertise leadership and mentoring to healthcare personnel in areas of competence.
  • Provide technical sales and networking support to the commercial team.

About the Company

BSI

Global standards and business improvement partner

BSI is a global standards and business-improvement partner that helps organizations grow by addressing society’s critical issues, from climate change to trustworthy AI. It works by developing and applying standards, certifications, training, assessment, and assurance services that enable clients to manage risk, improve governance, and demonstrate compliance. Its products operate through a worldwide network of experts, industry groups, and governments, delivering audits, certifications, and advisory guidance to help clients meet specified requirements and improve performance. What sets BSI apart is its scale and breadth: a 100-year history, a global community of 15,000 experts and 77,500+ clients across many sectors, and a collaborative approach with regulators, industry bodies, and stakeholders to implement standards in real-world operations. The company’s goal is to help clients fulfil theirs by creating trust and accelerating progress toward a fair society and a sustainable world.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
London, United Kingdom
Founded
1901

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