Product Reviewer – Contractor

Qualification

Bachelor's degree or higher in software engineering, computer science, electrical/electronic engineering or a closely related field. - Minimum 4 years of professional experience in the medical device industry or another safety-critical sector, including a minimum of 2 years designing, developing or testing safety-critical software. - Prior work as a Product Reviewer (technical documentation assessor) for a notified body or UK approved body, covering software devices (e.g. MDA 0315 / MDS 1011). - Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1 and medical device cybersecurity (e.g. IEC 81001-5-1, MDCG 2019-16). - Practical experience with software development fundamentals: lifecycle processes, verification and validation testing, configuration management and cybersecurity. - Evidence of confidently interpreting and applying regulatory requirements to software technical documentation. - Evidence of delivering consistent, high-quality technical documentation assessments. - Experience assessing software as a medical device (SaMD). - Ability to explain findings and requirements clearly and constructively, in writing and verbally. - Ability to deliver assessments inde