At a Glance
- Tasks: Provide regulatory expertise for Software as a Medical Device projects and guide customers through product development.
- Company: Join Binariks, a forward-thinking company focused on innovative solutions in the medical software field.
- Benefits: Flexible part-time role with opportunities for professional growth and collaboration.
- Other info: Collaborative environment with a focus on innovation and compliance.
- Why this job: Make a real impact in healthcare by ensuring compliance with UK medical software regulations.
- Qualifications: Expertise in UK medical software regulations and experience in preparing regulatory documentation.
The predicted salary is between 55000 - 65000 £ per year.
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
UK SaMD Subject Matter Expert (Part-time) employer: Binariks Inc.
Binariks is an exceptional employer that values expertise and innovation, particularly in the dynamic field of Software as a Medical Device (SaMD). With a strong focus on employee growth and collaboration, we offer a supportive work culture where your regulatory knowledge can thrive, especially in the UK market. Join us to be part of a team that not only prioritises compliance but also fosters meaningful contributions to healthcare technology.
