Global Quality and Accreditation: Technical and Regulatory Reviewer

TN United Kingdom; Spalding; Remote; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Technical and Regulatory Reviewer to enhance their global quality management systems for medical devices. This pivotal role involves ensuring compliance with ISO 13485 standards and supporting certification processes. You will engage with audit teams, provide technical expertise, and drive improvement projects. If you're passionate about quality assurance in the medical device sector and thrive in a collaborative environment, this opportunity offers a chance to make a significant impact on global health standards.

Qualifications

• Understanding of QMS requirements for medical devices.
• Experience in coordinating ISO 13485 audits.

Responsibilities

• Support ISO 13485 certification and CE schemes.
• Deliver certification decisions for ISO 13485 certifications.
• Provide technical support for medical device audits.

Skills

QMS requirements understanding

ISO 13485 knowledge

Audit coordination

Regulatory standards awareness

Medical device manufacturing experience

Education

Degree in a relevant field

Job description

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Global Quality and Accreditation: Technical and Regulatory Reviewer, Spalding

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Client:

BSI

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Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

65c22bdb163e

Job Views:

3

Posted:

02.05.2025

Expiry Date:

16.06.2025

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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 three main elements:

• Developing and maintaining technical expertise in key areas relating to certificate decision-making, competence verification, and competence monitoring;
• Supporting ad hoc improvement projects;
• Providing technical support for ISO 13485 certification schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE.

Responsibilities & Accountabilities:

• Support the rollout of policy decisions and processes for medical device QMS audits globally;
• Support ISO 13485 certification and CE schemes, including investigating customer appeals, report reviewing, and supporting regulator audits;
• Deliver certification decisions for ISO 13485 certifications as eligible, aiming to be qualified across all non-CE ISO 13485 schemes, resources permitting;
• Participate in smaller improvement projects ensuring adherence to procedures;
• Support hosting regulator or accrediting body audits;
• Provide advice and support to QMS auditors, technical specialists, scheme managers, sales, marketing, and other BSI colleagues on BSI QMS requirements for medical devices;
• Conduct competence verifier activities to support the auditor qualification process, if appropriate.

Suitable candidates should demonstrate:

• A good understanding of QMS requirements as applied to medical devices, including applicable regulations and standards (ISO 13485, MDD, AIMD, IVDD, MDR/IVDR, MDSAP);
• 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 in coordinating or conducting audits of medical device manufacturers to ISO 13485 (e.g., supplier or internal audits);
• Minimum of two years of hands-on medical device manufacturing experience and two years of quality management experience for medical devices.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These behaviors define how we operate at BSI and ensure a positive workplace and business success.

BSI is conducting face-to-face interviews where appropriate and possible. If invited to a face-to-face interview but prefer virtual, please inform our recruitment team.