Technical Reviewer - Active Medical Devices

BSI; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading standards organization is looking for a Technical Specialist & Scheme Manager for active devices. This home-based position offers the opportunity to work in a flexible environment and involves reviewing medical device documentation, managing certification activities, and providing regulatory support. Candidates should have at least 5 years of experience in medical device development and a relevant degree. The role facilitates continual professional development and offers competitive benefits.

Servizi

Competitive total rewards package

Ongoing training and development

Flexible working hours

Varied international job

Competenze

• Minimum of 5 years of R&D or testing experience with active medical devices.
• Thorough knowledge of Medical Device regulation.
• Understanding of design control and risk management principles.

Mansioni

• Review medical device technical and clinical documentation.
• Manage certification activities for medical device manufacturers.
• Provide regulatory and operational support to scheme managers.

Conoscenze

Design and development experience with medical devices

Strong interpersonal communication skills

Ability to prioritize and execute workload

Formazione

Bachelor’s degree in engineering or medical physics

Strumenti

Knowledge of IEC 60601 Third Edition

Knowledge of ISO 14971

Descrizione del lavoro

Job Title

Technical Specialist & Scheme Manager - Active Devices

Location

Home-based position located in the UK or Europe with up to 20% travel for training.

Responsibilities

• Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93 / 42 / EEC, MDR 2017 / 745 and UK MDR 2012 schemes.
• Manage certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications.
• Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes.
• Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.

Qualifications

• A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical devices.
• Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use such as electronic / electrical, electro-mechanical or biomedical engineering or medical physics.
• Thorough knowledge of Medical Device regulation; at minimum an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971.
• Understanding of the principles of design control and risk management.
• Strong interpersonal communication skills.
• Ability of prioritizing and executing individual workload.

Benefits

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development and a wide range of flexible benefits that you can tailor to suit your lifestyle.

How to Apply

Interested? To apply for this role please submit your application today and take the next step in your career as a Technical Reviewer with BSI.

D&I Policy

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. If you require any reasonable accommodations to be made on account of a disability or impairment throughout our recruiting process, please inform your Talent Acquisition Partner.