Global Quality and Accreditation: Technical and Regulatory Reviewer
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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 of three main elements :
- Developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring;
- Supporting in ad hoc improvement projects;
- Technical support of the ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE.
Responsibilities & Accountabilities :
- Support the roll out of policy decisions and processes for medical device QMS audits globally;
- Provide support of the ISO 13485 certification and CE schemes, for example investigating customer appeals, report reviewing and supporting activities during regulator audits;
- Deliver certification decisions for ISO 13485 certifications as eligible, with a goal to being qualified across all non-CE ISO13485 schemes, where resource allows;
- Participating in smaller improvement projects ensuring appropriate adherence to procedures;
- Support in hosting regulator or accrediting body audits
- Provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing and other BSI colleagues on BSI QMS requirements for medical devices;
- Competence verifier activities to support the auditor qualification process, if appropriate.
Suitable candidates should demonstrate the following :
- A good understanding of QMS requirements as applied to medical devices including applicable regulations and standards (ISO 13485 and MDD, AIMD and / or IVDD, MDR / IVDR and MDSAP requirements in particular).
- 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 of co-ordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits)
- Minimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices.
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They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.