Binariks is looking for a UK SaMD Subject Matter Expert to join our Solution Group on a part-time basis as a domain expert supporting presales and discovery activities.
In this role, you will provide regulatory expertise for Software as a Medical Device (SaMD) projects, helping shape solution proposals, assess compliance requirements, and guide customers through the early stages of product development. You will collaborate with cross-functional teams to ensure proposed solutions align with UK regulatory standards and industry best practices.
What We’re Looking For: * Proven expertise in UK medical software regulations, including MHRA, UK MDR 2002, and EU MDR * Deep knowledge of UKCA conformity assessment, MHRA device registration, and SaMD qualification and classification * Hands-on experience preparing SaMD regulatory documentation (including UKCA/MHRA compliance artifacts i.e. technical files, risk files per ISO 14971, IEC 62304 lifecycle documentation) * Familiarity with NHS compliance requirements, including DTAC and DCB0129/DCB0160 clinical safety documentation * Experience supporting presales and discovery activities * Excellent communication and stakeholder management skills * Upper-Intermediate (B2) or higher level of English
Your Responsibilities: * Act as the UK SaMD regulatory expert during presales and discovery engagements * Advise customers and internal teams on UK medical device regulatory requirements and compliance strategies * Assess SaMD qualification, classification, and applicable regulatory pathways * Prepare and review regulatory and compliance documentation, support the creation of technical files, risk management documentation, and other compliance artifacts * Identify regulatory risks and recommend compliant technical approaches * Collaborate with business, delivery, and engineering teams to ensure regulatory requirements are considered from the early stages of each engagement * Participate in customer meetings, workshops, and discovery sessions
