Technical Specialist, Clinical Evaluation Specialist – SaMD

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Develop, oversee, and manage a portfolio of CE marking schemes for Medical Devices.

• Conduct assessments of technical documentation to support CE marking initiatives.

• Offer leadership and mentorship in Medical Device expertise to Healthcare professionals.

• Organize and execute Technical File Assessments, Design Examinations, and Unannounced Audits to facilitate EC Certification.

• Manage client projects, serving as the main point of contact, and make certification recommendations for CE, UKCA, and ISO 13485 certificate issuance to ensure compliance, timely service delivery, and client satisfaction.

• Provide technical support to the commercial team as needed to aid in business development and marketing efforts.

• Conduct unannounced inspections of medical device manufacturers worldwide as a technical expert to ensure compliance with certification requirements.

• Collaborate with the Line Manager and other team leaders as necessary to offer reviews within areas of expertise.

⛳️ Requirements

• Minimum of 4 years of experience in a technical role related to Software Medical Devices.

• Proficient in interpreting and applying International and National standards relevant to the design, development, and regulation of software medical devices.

• Knowledgeable in Risk Management and FMEA pertaining to Software Medical Devices.

• Comprehensive technical understanding of medical devices.

• Awareness of companies operating in this sector and current industry trends.

• Bachelor's degree or equivalent in a field related to medical device design, development, manufacturing, and usage, such as electro-mechanical, electronic/electrical, biomedical engineering, computer science, medical physics, or similar.

🏝️ Benefits

• 20 days of annual leave.

• Bank holidays.

• Medical, dental, and vision insurance.

• Life insurance.

• 401(K) plan with company contribution.

• Short-term and long-term disability coverage.

• Maternal leave.

• Paid parental leave.

• Paid bereavement leave.

• Opportunities for learning and development.

• Flexible benefits that can be customized to fit your lifestyle.