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EU Regulatory Lead (IVD)
Solliciteer als één van de eersten
For over 100 years BSI has shaped standards of excellence adopted by organizations world-wide.
  • BSI began in 1901 with the 1st meeting of the engineering Standards Committee, convened by John Wolfe-Barry, designer of London’s Tower Bridge.
  • In 1903 our Kitemark was registered and as such is one of the oldest Trustmarks still in use today.
  • BSI was the first National Standards Body and a founding member of the International Organization for Standardization (ISO).
  • Our 3rdGeneration of Standards are centred around behaviour and values to help organizations reach their full potential through their people.

Jouw verantwoordelijkheden

Overview / Purpose of the position:
  • Provide regulatory support to the Head of NB IVDR in the establishment and maintenance of the designations as a NB for the applicable Medical Devices Regulations.
  • Responsible for the conformity assessment & certification activities related to the scope of the designations the NB operates under and ensure that the CAB is operating in compliance with the applicable regulatory requirements.
Key Success / Performance Indicators:
Regulatory compliant processes:
  • Support processes and procedures to be a fully compliant NB with no systematic non-conformities at audit;
  • Meet KPIs to address internal and external NC from audits to restore compliance;
Quality Management Requirements:
  • Support processes and procedures to be a fully compliant NB with no systematic non-conformities at audit;
  • Meet KPIs for Document Approval tasks to ensure continuous regulatory compliance and support implementation of the procedures, e.g., by developing and delivering training;
  • Attend Document Approval Consistency meetings to ensure a harmonised process that continuously improves;
  • Develop or revise existing QMS documents to reflect the current Regulatory Requirements;
  • Own and update relevant QMS documents;
  • Develop and deliver internal /external training in areas of expertise;
  • Regulatory thought leadership – author white papers and webinars;
Resource Requirements:
  • Meet KPIs for Competence Verification thereby ensuring the NB has sufficient qualified resources to cover the scope of its designations, as documented in the Competence Matrix;
  • Attend Competence Verification Consistency meetings to ensure a harmonised process that continuously improves;

Jouw profiel

Knowledge and Experience:
  • An understanding of BSI, its role and the approach of Regulatory Services (Medical Device) to Conformity Assessment Activities and Certification for CE / UKCA marking;
  • Thorough knowledge of Medical Devices Regulations and related Guidance documents (e.g. MHRA, MDCG);
  • Thorough knowledge of Conformity Assessment; Process per QMS standards ISO/IEC 17021-1 and approach to ISO 13485 Certification/Registration;
  • An understanding of the establishment and maintenance of a designated Conformity Assessment Body (i.e. NB2797 and AB0086) for the Medical Devices Regulations (EU & UK, respectively). Notified Body listing the designations and scope of designation on the EC Website NANDO;
  • Conformity Assessment Body (i.e., NB & AB), product and quality systems standards and requirements;
  • An understanding of product and QMS conformity assessment routes and certification concepts and principles;
  • A comprehensive understanding of technical documentation required from medical device manufacturers addressing the applicable regulations and standards;
  • A comprehensive understanding of quality systems, philosophies and principles and internal auditing principles and practices;
  • Experience in Medical Device Industry, i.e., Quality Management System processes (ISO13485) and R&D – Product Development and Manufacturing processes, Risk management Process and Regulatory aspects of Device Certification/Registration.
  • We expect you are familiar with UKCA regulation if based in UK.
Skills and Abilities:
  • Conceptual and analytical thinking, efficiency and results orientation
  • A team player good at relationship building internally and externally with authorities and clients and other stakeholders;
  • Broad technical understanding of client industry products (materials, processing, assembly, clinical use of products)
  • General knowledge of business principles and operating practices (commercial awareness)
  • Ability to understand and interpret legislation and input to policy.
  • Influencing skills
Education / Qualifications:
  • First or second degree in engineering, science or related discipline
  • Good interpersonal skills, particularly communication and influencing skills
  • Driven / Enthusiastic
  • Local hire only.

Ons aanbod

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.
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BSI Group The Netherlands B.V.Nederland, Nederland
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