Global Quality and Accreditation : Technical and Regulatory Reviewer

BSI; Madrid; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company is seeking a Global Quality & Accreditation: Technical and Regulatory Reviewer to oversee medical device quality management systems globally. The role includes maintaining technical expertise, supporting ISO certifications, and auditing policies. Candidates should have a solid understanding of QMS regulations, experience in medical device audits, and a commitment to quality excellence.

Formación

• Good understanding of ISO 13485 and medical device regulations.
• Experience in conducting audits to ISO 13485.
• Comprehensive understanding of quality systems.

Responsabilidades

• Support rollout of policy decisions for medical device QMS audits.
• Provide support for ISO 13485 certification and CE schemes.
• Deliver certification decisions for ISO 13485 certifications.

Conocimientos

Understanding of QMS requirements

Experience in conducting audits

Awareness of certification and accreditation roles

Educación

Two years of hands-on medical device manufacturing experience

Two years quality management experience for medical devices

Descripción del empleo

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 :

• 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.

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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