Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD

BSI; United Kingdom; Remote; GBP 40,000 - 60,000; Full time

Job summary

BSI is seeking a Technical Specialist to manage CE marking schemes for medical devices, specifically in Software as a Medical Device (SaMD). The role involves technical assessments, client project management, and ensuring compliance with relevant standards. Ideal candidates will have extensive experience in the field and relevant academic qualifications.

Benefits

Competitive salary

Ample annual leave and paid time off

Professional development opportunities

Qualifications

• 4+ years of experience in Software Medical Device in a technical role.
• Degree in biomedical engineering, computer science, or related field.

Responsibilities

• Plan and deliver Technical File Assessments and audits for EC Certification.
• Manage client projects and ensure compliance with certification.
• Provide technical support for business development activities.

Skills

Software Medical Device experience

Risk Management

Technical understanding of medical devices

Education

Bachelor's degree in relevant field

Job description

Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD

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Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD

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Job Title: Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD

Reports to: Technical Team Manager

Location: Home Based – Global

We have exciting opportunities for medical device software specialists to join our Software team. You will have the opportunity to work with medical device manufacturers across the globe, from dynamic start-ups through to established large manufacturers. We are seeking engineers with SaMD (Software as a Medical device) in technical capacity which can include product design, development and/or testing.

Purpose of the position

To build, manage, develop, control and manage a portfolio of Medical Device CE marking schemes. To deliver technical documentation assessments in support of the CE marking schemes. To provide Medical Device expertise leadership and mentoring in areas of competence to Healthcare personnel.

Key Responsibilities & Accountabilities

• 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 as it grows the customer base worldwide.
• 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.
  
  
  

Essential Criteria

• 4 or more years of Software Medical Device experience in a technical capacity, preferably within product design, development and/ or testing.
• 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.
  
  
  

Qualifications

• 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
  
  
  

What We Offer

BSI offers a competitive salary, ample annual leave/paid time off, and other robust benefits depending on country. We invest strongly in the development of our experts, a highlight being an annual conference where our hundreds of experts come together for intensive and exciting continued professional development.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider

• Industries

  Professional Services

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