EU IVD Regulatory Lead
il y a 3 semaines
At BSI, we are seeking a highly skilled Regulatory Lead to join our team. As a key member of our Medical Devices Regulatory team, you will play a critical role in ensuring compliance with regulatory requirements and maintaining our designation as a Notified Body.
Key Responsibilities:- Provide regulatory support to the Head of Notified Body IVDR in the establishment and maintenance of designations as a Notified Body for applicable Medical Devices Regulations.
- Responsible for conformity assessment and certification activities related to the scope of the designations the Notified Body operates under, ensuring compliance with applicable regulatory requirements.
- Support Compliance and Risk, Human Resources, and Legal with processes related to legal status, organizational 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 requirements of relevant medical devices regulations, other applicable legislation, relevant external documents, and BSI-specific requirements.
- Ensure regulatory requirements are appropriately laid down in the QMS (policies, procedures, forms, guidance notes, and work instructions).
- 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 processes and procedures to be a fully compliant Notified Body with no systematic non-conformities at audit.
- Meet KPIs to address internal and external NC from audits to restore compliance.
As a Regulatory Lead, you will be a key member of our team, working closely with stakeholders to ensure regulatory compliance and maintain our designation as a Notified Body. If you have a strong understanding of medical devices regulations and a passion for regulatory compliance, we encourage you to apply for this exciting opportunity.
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