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Global Quality and Accreditation: Technical and Regulatory Reviewer, Spalding
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Client:
BSI
Location:
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
65c22bdb163e
Job Views:
3
Posted:
02.05.2025
Expiry Date:
16.06.2025
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Job Description:
Great that you're thinking about a career with BSI!
Role Title: Global Quality & Accreditation: Technical and Regulatory Reviewer
Reporting: Global Quality & Accreditation: Technical Manager
Location: UK/EU/APAC - Homebased
The role is to provide medical device quality management system ownership to medical device and QMS audit teams globally.
The role comprises three main elements:
* Developing and maintaining technical expertise in key areas relating to certificate decision-making, competence verification, and competence monitoring;
* Supporting ad hoc improvement projects;
* Providing technical support for ISO 13485 certification schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE.
Responsibilities & Accountabilities:
* Support the rollout of policy decisions and processes for medical device QMS audits globally;
* Support ISO 13485 certification and CE schemes, including investigating customer appeals, report reviewing, and supporting regulator audits;
* Deliver certification decisions for ISO 13485 certifications as eligible, aiming to be qualified across all non-CE ISO 13485 schemes, resources permitting;
* Participate in smaller improvement projects ensuring adherence to procedures;
* Support hosting regulator or accrediting body audits;
* Provide advice and support to QMS auditors, technical specialists, scheme managers, sales, marketing, and other BSI colleagues on BSI QMS requirements for medical devices;
* Conduct competence verifier activities to support the auditor qualification process, if appropriate.
Suitable candidates should demonstrate:
* A good understanding of QMS requirements as applied to medical devices, including applicable regulations and standards (ISO 13485, MDD, AIMD, IVDD, MDR/IVDR, MDSAP);
* A good understanding of product and QMS certification concepts and principles;
* A comprehensive understanding of quality systems, philosophies, and principles;
* An awareness of certification, accreditation, and notified body roles;
* Experience in coordinating or conducting audits of medical device manufacturers to ISO 13485 (e.g., supplier or internal audits);
* Minimum of two years of hands-on medical device manufacturing experience and two years of quality management experience for medical devices.
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These behaviors define how we operate at BSI and ensure a positive workplace and business success.
BSI is conducting face-to-face interviews where appropriate and possible. If invited to a face-to-face interview but prefer virtual, please inform our recruitment team.
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