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 schemes, where resource allows
Competence verifier activities to support the auditor qualification process
Support the roll out of policy decisions and processes for medical device QMS audits globally
Participating in smaller improvement projects ensuring appropriate adherence to procedures
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

Previous 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 manufacturing experience and two years quality management experience
First or second degree in engineering, science or related discipline
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

Medical Device Technical/Regulatory Reviewer

Key skills