Jobs in Marbella, United States

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Client: BSI

Location: Spain

Job Category: Other

EU work permit required: Yes

Job Views: 3

Posted: 06.03.2025

Expiry Date: 20.04.2025

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 regulatory 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. Participate 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 coordinating 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.