[Hiring] Medical Device Technical/Regulatory Reviewer @BSI

Role Description

We have an exciting opportunity for a Technical /Regulatory Reviewer to join our Regulatory Services Global Quality & Accreditation team. 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.

The position will report to the Global Quality and Accreditation Technical Manager- Medical Devices and is home based. Some travel to BSI and third-party locations around the globe for training delivery, conferences and business meetings is desirable, but is not mandatory.

Responsibilities

• 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.

Qualifications

• 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.

Benefits

• Competitive total reward package.
• Independent and varied job in an international environment.
• Flexible working hours.
• Ongoing training and development.