EU IVD Regulatory Lead

il y a 1 semaine

Metz, Grand Est, France BSI Temps plein

Job Title: Regulatory Lead for Medical Devices in the EU

Job Summary:

BSI is seeking a highly skilled Regulatory Lead to join our team in the EU. As a Regulatory Lead, you will be responsible for providing regulatory support to the Head of Notified Body IVDR in the establishment and maintenance of designations as a Notified Body for the applicable Medical Devices Regulations.

Key Responsibilities:

  • Provide regulatory support to the Head of Notified Body IVDR in the establishment and maintenance of designations as a Notified Body for the applicable Medical Devices Regulations.
  • Responsible for the conformity assessment and certification activities related to the scope of the designations the Notified Body operates under and ensure that the Certification Body is operating in compliance with the applicable regulatory 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 the maintenance of accreditation.
  • Establish, implement, and maintain a quality management system (QMS) that is appropriate to the nature, area, and scale of BSI's conformity assessment activities.
  • Document Approver activities: Demonstrate the consistent fulfillment 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 authorizing 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  • Ensure timely withdrawal of superseded or withdrawn QMS documents from BMS.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".
  • Support Internal Training to develop and deliver training to ensure that the Regulatory Requirements and BSI's QMS are fully understood.
  • Competence Verification activities: Support Internal Training to review initial qualification, re-qualifications, and authorizations 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.
  • 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), and handling 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.
  • 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.
  • 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.
  • Document Approving, Competence Verification, and Decision Making are considered "Internal Activities" the Regulatory Lead should be "employed" by the Notified Body.

Requirements:

  • 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 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).
  • 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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