EU IVD Regulatory Lead

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Job Title: Regulatory Lead EU

Reports to: Head of Notified Body IVDR

Location:  EU – homebased

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.

Responsibilities & Accountabilities:

Organisational & General Requirements:

Support Compliance and Risk, Human Resources and Legal with processes related to: Legal Status, Organisational Structure, Independence and Impartiality, Confidentiality, Liability and Financial Requirements Work in collaboration with Designating / Competent Authorities and Participate in Coordination Activities Support Global Quality and Accreditation in maintenance of accreditation

Quality Management Requirements:

Establish, implement and maintain a quality management system (QMS) that is appropriate to the nature, area, scale of BSI’s conformity assessment activities. Document Approver activities:Demonstrate the consistent fulfilment of the requirements of the relevant medical devices regulations, other applicable legislation, relevant external documents (e.g. guidance and standards) and BSI specific requirements;Ensure regulatory requirements are appropriately laid down in the QMS (policies, procedures, forms, guidance notes and work instructions);Ensure new QMS documents or changes to the existing documents are reviewed, approved and subsequently implemented by authorising publication (upload) on BSI’s business management system (BMS). Ensure timely withdrawal of superseded or withdrawn QMS documents from BMS;Assign ownership of procedures to BSI’s Subject Matter Experts (i.e., Document Owners);Review and approve marketing material for distribution by the commercial team;Review and approve “Screening Reports of Medical Devices External Documents” and “Screening Reports of scientific, clinical data and post-market information relating to the scope of its designation”; Training activities:Support Internal Training to develop and deliver training to ensure that the Regulatory Requirements and BSI’s QMS fully understood;

Resource Requirements:

Competence Verification activities:Support Internal Training to review initial qualification, re-qualifications and authorisations of employees to conduct specified conformity assessment, certification and supporting activities linked to the assigned competence codes;Establish qualification criteria for competence codes;Verify the competence for roles Scheme Manager, Technical Specialist, Certificate Decision Maker, Unannounced Auditor, Clinical Reviewer, Competence Verifier, Document Approver.

Process Requirements:

Build relationships with authorities, i.e., the European Commission, the Designating Authorities (NL-VWS; UK-MHRA) and the National Competent Authorities of the EU-Member States by:Participating in designation / surveillance audits from authorities;Responding promptly to requests / queries from authorities (e.g. COEN (CEF) requests);Handle issues that arise effectively Represent BSI in stakeholder meetings and regulatory forums (NBCG-MED; EU/UK Working groups MDCG; TEAM-NB); Provide leadership, mentoring and monitoring in areas of conformity assessment, certification, competence of personnel, To ensure regulatory compliant processes within BSI, the Regulatory Lead is a member of the Global Regulatory Compliance Team, working together with Compliance & Risk, Clinical Compliance, Global Quality and Accreditation and Training Team. Furthermore, the Regulatory Leads participate in the Compliance (Operations) Reviews of the Technology Teams. Certificate Decision Making:Conduct Regulatory and Quality Review of the output from Conformity Assessment activities to verify the reports and supporting documentation of an assessment are complete and decide whether the regulatory requirements and BSI-specific requirements have been fulfilled before granting (continued) certification;Make decisions on issuing, refusing, changing (extension to scope or restriction to scope), suspending, re-instating or withdrawing (cancellation) of certificates and for defining the period of certification. The decision is based on the final review completed by the Scheme Manager. The final decision is documented and signed;Regulatory Lead participates in International Schemes, e.g. develop and implement processes for Global Schemes; Complete reviews resulting in regulatory letters that support Clients in Global Medical Device applications; Document Approving, Competence Verification and Decision Making are considered “Internal Activities” the Regulatory Lead should be “employed” by the NB.

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;

Travel requirements:

Home based, travelling max 10x per year . The role will involve some travel e.g. to BSI offices for (team) meetings, to authorities (e.g. MHRA; VWS; IGJ; EC; NBO-Med; Task Force/Working Groups; Other) and to third party locations around the globe for training, business and representative meetings (stakeholders) or audits.

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.

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 Good interpersonal skills, particularly communication and influencing skills Capable of operating with horizontal and vertical reporting lines Driven / Enthusiastic.

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 is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

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