Job Description, Responsibilities & Requirements
About the Position
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.
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
Requirements
- 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
We Offer
- Opportunity to work with a leading company in the fintech sector
- Collaborative and innovative work environment
- Potential for professional growth and development
About the Company
Binariks is a company that specializes in providing regulatory expertise for Software as a Medical Device projects, ensuring compliance with UK and EU regulations.