Technical Specialist – Active Medical Devices

Job not on LinkedIn

🕒 June 30

🌐 United Kingdom, Canada, +5 more countries – Remote

🇬🇧 United Kingdom – Remote 🇨🇦 Canada – Remote 🇰🇷 South Korea – Remote 🇮🇹 Italy – Remote 🇪🇸 Spain – Remote 🇫🇷 France – Remote 🇺🇸 United States – Remote

💵 £58.5k - £78k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 25%

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BSI

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1901

💼 Consulting

🏗️ Construction

📦 Logistics

Consulting • Construction • Logistics

BSI is a global Standards organization committed to helping organizations improve their performance and ensure safety, quality, and sustainability. As the UK National Standards Body, BSI provides a wide range of services, including certification, training, and assessment across various sectors such as healthcare, construction, and energy. BSI empowers businesses to adopt best practices and drive positive change through robust standards development and innovative solutions for a resilient digital future.

📋 Description

• Review and evaluate medical device technical and clinical documentation 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 determining auditing requirements and recommending the issue and maintenance of CE certifications • Provide specialist regulatory, operational and strategic support to medical device scheme managers, product specialists and the business in delivering CE medical device marking schemes • Provide medical device expertise leadership and mentoring to medical devices personnel • Work with medical device manufacturers throughout their certification lifecycle to place active medical devices on the European market • Assess cutting-edge technology affecting patient health and safety • Apply engineering and design knowledge, regulatory expertise, English writing skills, client management and project management

🎯 Requirements

• Four years' professional experience in the field of healthcare products or related activities, such as manufacturing, auditing or research • Two years of experience in the design, manufacture, testing or use of the device or technology to be assessed, or related to the scientific aspects to be assessed • Bachelor’s or higher degree in a discipline relevant to the medical device industry, including electronic/electrical, electro-mechanical or biomedical engineering or medical physics • Familiarity with the Medical Devices Regulation (EU) 2017/745 and/or Medical Devices Directive 96/42/EEC is an advantage • Awareness of the requirements of the IEC 60601 family of standards and ISO 14971 risk management standard • Understanding of design control and risk management principles • Strong interpersonal communication skills • Ability to prioritize and execute individual workload • Professional experience in accredited testing laboratories and broad exposure to a range of active medical devices are advantageous

🏖️ Benefits

• Competitive total reward package • Flexible working hours • Ongoing training and development • Reasonable accommodations throughout the recruiting process for disability or impairment • Equal opportunity and diverse, inclusive workplace • Opportunities to develop, grow, and engage with the global organization