EU IVD Regulatory Specialist
il y a 1 jour
As a Regulatory Lead EU at BSI, you will play a critical role in ensuring regulatory compliance and maintaining the company's reputation as a trusted partner in the medical devices industry.
The Regulatory Lead EU will provide regulatory support to the Head of Notified Body IVDR in establishing and maintaining designations as a Notified Body for Medical Devices Regulations. This includes providing conformity assessment and certification activities related to the scope of the designations the Notified Body operates under.
Key Responsibilities:- Provide regulatory support to the Head of Notified Body IVDR in establishing and maintaining designations as a Notified Body for Medical Devices Regulations.
- Responsible for conformity assessment and certification activities related to the scope of the designations the Notified Body operates under.
- Ensure that the Conformity Assessment Body (CAB) operates in 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.
- Work in collaboration with Designating / Competent Authorities and Participate in Coordination Activities.
- Support Global Quality and Accreditation in maintenance of accreditation.
- Establish, implement and maintain a quality management system (QMS) that is appropriate to the nature, area, scale of BSI's conformity assessment activities.
- Document Approver activities: Demonstrate the consistent fulfilment of the requirements of the relevant medical devices regulations, other applicable legislation, relevant external documents (e.g. guidance and standards) and BSI specific requirements.
- Training activities: Support Internal Training to develop and deliver training to ensure that the Regulatory Requirements and BSI's QMS fully understood.
- Competence Verification activities: Support Internal Training to review initial qualification, re-qualifications and authorisations 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.
- 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.
- 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.
- 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.
- 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).
At BSI, we value Client-centric, Agile, Collaborative behaviours, which represent how we do things at BSI.
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