UK SaMD Subject Matter Expert (Part-time

UK SaMD Subject Matter Expert (Part-time)

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.

• 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 DCB
  0129/DCB
  0160 clinical safety documentation
• Experience supporting presales and discovery activities
• Excellent communication and stakeholder management skills
• Upper-Intermediate (B2) or higher level of English

• 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