Technical Specialist, Clinical Evaluation Specialist – SaMD

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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BSI

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1901

📋 Compliance

Compliance • Healthcare • Sustainability

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

• Build, manage, develop, control and manage a portfolio of Medical Device CE marking schemes • Deliver technical documentation assessments in support of the CE marking schemes • Provide Medical Device expertise leadership and mentoring in areas of competence to Healthcare personnel • Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits to support EC Certification • Manage client projects, acting as their primary contact and after satisfactory assessment, to make certification recommendations for CE, UKCA, and ISO 13485 certificate issue to ensure compliance with required certification, timely delivery of services and client satisfaction • Act as technical support to the commercial team when required to support business development and marketing activities • Perform unannounced visits to medical device manufacturers globally as a technical expert to check on compliance with certification • Work with Line Manager and other team leaders as required to provide reviews within area of expertise

🎯 Requirements

• 4 or more years of Software Medical Device experience in a technical capacity • Interpretation and applications of International and National standards for the design, development, and regulation of software medical devices • Understanding of Risk Management and FMEA of Software Medical Devices • Broad technical understanding of medical devices • Understanding of companies operating in these spaces and current industry trends • Degree educated (Bachelor’s minimum or equivalent) relevant to medical device design, development, manufacture, and use i.e. electro-mechanical, electronic/electrical, biomedical engineering, computer science, medical physics or similar

🏖️ Benefits

• 20-days annual leave • Bank holidays • Medical, dental, and vision insurance • Life insurance • 401(K) with company contribution • Short-term and long-term disability • Maternal leave • Paid parental leave • Paid bereavement leave • Learning and development opportunities • Flexible benefits that you can tailor to suit your lifestyle