Overview
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Job title: Technical Specialist & Scheme Manager - Active Devices
Location: Homebased in APAC: China, Taiwan or Japan, UK, EMEA, US, Canada
BSI is seeking experienced R&D Engineers to join our Active Medical Devices team as a home-based Technical Specialist & Scheme Manager (Technical Reviewer). If you have hands on experience in the Research, Design or Manufacture of Active Medical Devices we'd love to hear from you.
As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, client and project management. You will assess cutting edge technology that will make a difference in patient health and safety and broaden your technical knowledge through ongoing 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. This may include electronic/electrical, electro-mechanical or biomedical engineering or medical physics.
* Our focus at the moment is R&D experience across the following: Respiratory devices e.g. ventilators, Anaesthesia or Incubators however, if you have a strong R&D experience with active medical devices then we'd love to hear from you.
* 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.
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.
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.
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About Us
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner.
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Diversity & Inclusion 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. BSI is a community where everyone can thrive.
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.
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