Global Quality and Accreditation: Technical and Regulatory Reviewer, Lincolnshire

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Global Quality and Accreditation: Technical and Regulatory Reviewer, Lincolnshire

Client:

BSI

Location:

Lincolnshire, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

65c22bdb163e

Job Views:

7

Posted:

03.03.2025

Expiry Date:

17.04.2025

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 of three main elements:

1. Developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring;
2. Supporting in ad hoc improvement projects;
3. 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:

1. Support the roll out of policy decisions and processes for medical device QMS audits globally;
2. Provide support of the ISO 13485 certification and CE schemes, for example investigating customer appeals, report reviewing and supporting activities during regulator audits;
3. Deliver certification decisions for ISO 13485 certifications as eligible, with a goal to being qualified across all non-CE ISO13485 schemes, where resource allows;
4. Participating in smaller improvement projects ensuring appropriate adherence to procedures;
5. Support in hosting regulator or accrediting body audits;
6. 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;
7. Competence verifier activities to support the auditor qualification process, if appropriate.

Suitable candidates should demonstrate the following:

1. 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).
2. A good understanding of product and QMS certification concepts and principles.
3. A comprehensive understanding of quality systems, philosophies and principles.
4. An awareness of certification, accreditation and notified body roles.
5. Experience of co-ordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits).
6. 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.