Regulatory Lead EU
il y a 2 semaines
At BSI, we are seeking a highly skilled Regulatory Lead EU to join our team. As a key member of our Regulatory Services department, you will be responsible for providing regulatory support to our 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 NB 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 CAB 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 maintenance of accreditation.
- 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.
- 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.
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