Compliance and Risk Manager

hace 4 días

Madrid, Madrid, España Bsi A tiempo completo

About the Role:

As a Compliance and Risk Manager at BSI, you will play a critical role in ensuring the company's compliance with accreditation and designation requirements for all regulatory services certification activities. This includes supporting the management of BSI's quality management system processes for management review, internal audits, complaints, appeals, concessions, CAPAs, and document control.

Key Responsibilities:

  • Work with the business to develop and document procedures that ensure consistent service delivery compliant with standards and regulations.
  • Provide support in the Compliance and Risk interface with regulatory bodies, including managing external audits and closing non-conformities.
  • Carry out internal audits in the Regulatory Services business stream for compliance and improvement according to applicable standards.
  • Maintain CAPA, Concessions, Impartiality, Appeals, Complaints, and other RS compliance processes, as well as BMS maintenance and procedural compliance of all RS documentation.
  • Provide advice to the business on developing new and revised services and products, taking cognizance of risks to the business.
  • Offer general advice and guidance to the Regulatory Services team on risk, legal, technical, regulatory policy, and procedural issues.
  • Deliver training where required to the Regulatory Services stream.
  • Perform any other duties required to support and develop the Regulatory Services Compliance and Risk Team.

Requirements:

  • Degree or equivalent and relevant experience.
  • Good understanding of product certification concepts and principles.
  • Good understanding of quality systems, philosophies, and principles, as well as internal auditing principles and practices.
  • Good understanding of the application of accreditation/designation, notified body, product, and quality systems standards and requirements.
  • Good understanding of Medical Devices manufacturers' or AI Industry QMS assessment techniques.
  • ISO 13485 auditor qualification or capability to gain ISO 13485 auditor qualification.
  • ISO 27001/42001 auditor qualification or capability to gain ISO 27001/42001 auditor qualification (preferred).

What We Offer:

As a team member at BSI, you will enjoy an extensive, competitive total rewards package, including annual leave, bank holidays, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.

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