EU Medical Devices Regulatory Compliance Specialist
il y a 23 heures
We are seeking a highly skilled Regulatory Lead to join our team at BSI, responsible for ensuring our conformity assessment and certification activities are fully compliant with the applicable Medical Devices Regulations in the EU.
As a key member of our Global Regulatory Compliance Team, you will work closely with Compliance and Risk, Clinical Compliance, Global Quality, and Accreditation, as well as Training Team to ensure regulatory compliant processes within BSI.
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, ensuring compliance with 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.
- Collaborate with Designating/Competent Authorities and participate in coordination activities.
- Support Global Quality and Accreditation in the maintenance of accreditation.
- Thorough knowledge of Medical Devices Regulations and related Guidance documents.
- Experience in the Medical Device Industry, including Quality Management System processes (ISO 13485) and R&D – Product Development and Manufacturing processes.
- Ability to understand and interpret legislation and input to policy.
- Conceptual and analytical thinking, efficiency, and results orientation.
- Broad technical understanding of client industry products (materials, processing, assembly, clinical use of products).
- General knowledge of business principles and operating practices.
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