Global Quality and Accreditation: Technical and Regulatory Reviewer
5 months ago
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 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:
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.Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. 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.
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