Clinical Evaluation Specialist

Scarlet

We pull medical technology from the future to solve human health.   Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue. ABOUT THIS ROLE: Scarlet’s Devices function is a team of clinicians, AI experts, and software engineers, working together to assess and certify the most innovative and impactful medical device software. We pride ourselves on delivering fast and efficient assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices. As we continue to scale our activities and certify more and more medical devices, we need clinical and regulatory expertise to provide support across all stages of the customer journey. You’ll join a team of clinical evaluation experts, conducting swift and accurate device assessments, whilst providing knowledge and expertise to internal functions and external stakeholders. YOUR RESPONSIBILITIES: * Get authorised to assess the clinical evaluation processes of the most innovative medical devices in the world * Collaborate with a multidisciplinary team on technical documentation assessments * Create content to help explain complex regulatory topics to customers and prospects * Screen and action regulatory insights from the latest research, standards and guidance * Support the Sales and Customer Experience function by providing regulatory insights on prospects and customers * Work with our Product, Engineering, Design and Applied ML functions to build and improve our systems * Support the Technical Operations function as they expand Scarlet’s approvals in various jurisdictions and technologies THE KEY SKILLS: * Education - A degree in clinical medicine, nursing, radiography, medical physics, biomedical engineering, or a related discipline * Work experience - Minimum of two years experience in patient care, clinical imagining, radiology operations, or related healthcare practice * Work experience - Experience using medical device software or active non-implantable imaging devices utilising ionising radiation (e.g. x-ray computer tomography, gamma cameras, fluoroscopy, PET scanners) * Work experience - Minimum of two years experience with the assessment of clinical data for medical devices * Work experience - Knowledge of the fundamental principles of the assessment of clinical data for medical devices and medical statistics * Work experience - Practical experience in conducting or monitoring clinical investigations/trials or assessing clinical data DESIRABLE SKILLS: * Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo * Research savvy - You have knowledge of different clinical research methodologies, including experience designing or contributing to the development of clinical trials * Excellent communicator - You have exceptional written & verbal communication skills * Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks * Guidance knowledge - You have knowledge or training in the relevant standards and guidance used for clinical evaluation (e.g. ISO 14155, MEDDEV 2-7/1 Rev.4) THE INTERVIEW PROCESS 1. Intro call with Kim - 20 mins 2. Interview with Sandy - 45 mins 3. Technical interview with Kim - 1 hour 4. Culture and values interview with James and Jamie - 2x30 mins 5. Referencing & offer

Beam

At Beam, you get to do work that matters for the world. We’re solving the world's toughest social problems with an incredible team, tech and AI. And we’re growing fast 🚀 It’s not easy. Nothing worth doing ever is. Join a company at the forefront of social impact, driving first-of-its-kind positive change. You’ll be part of a high-performance culture where you'll make a huge impact, rapidly progress your career, and truly enjoy your work. From top-tier coaching and personal development budgets to competitive salaries, we take care of everyone who works at Beam. We’ve already seen incredible growth from our Beam Notes product, helping frontline workers save over 8 hours of admin per week. From social workers and NHS clinicians to mental health practitioners and safeguarding specialists, nearly 100,000 frontline workers across the UK, US and Australia are now using Beam Notes regularly to deliver faster, more human-centred support. Are you an expert in all things medical device regulation and healthtech, who thrives in high ownership, cross-functional roles? We are looking for a Healthcare Compliance Manager to own clinical compliance and regulation across our healthcare products. In this highly operational, high-ownership role, you will drive Beam towards Class IIa medical device certification for our products, while being the day-to-day contact for all things cross-functionally healthcare. You will be the guardian of our clinical regulatory status - from DCB documentation and ISO standards through to our quality management system, ongoing clinical evaluations, and our engagement with the MHRA and DHSC. This isn't your typical regulatory role. We're building out a healthcare team and you'll be our detail-oriented "founding generalist" within it, wearing many hats. In a typical week you might: progress a Class IIa submission, shape the healthcare product roadmap with our PM, scope an NHS EPR integration, run a clinical evaluation, train the team on a new process, and bring in external advice exactly where we need it. You'll set the roadmap for our clinical operations and have a clear sense of when to expand or hire in additional resource. We are keen to use AI to automate wherever we can, and we'll encourage you to find efficiencies in how we work, meaning your focus stays on high-accuracy regulatory review, strategic planning, and being the subject-matter expert the whole company can rely on. This is an incredible opportunity to learn the ins and outs of our technical architecture, master the regulatory pathway for AI-enabled medical software, and play a pivotal role in driving rapid growth in the healthcare side of our business. You'll be * Owning clinical compliance and the regulatory roadmap: Taking ownership of medical device classifications and DCB documentation, and driving Class IIa medical device regulation for our products. * Driving certification through to completion: Owning timely audits, compliance, and submissions, while building out the QMS and the processes within the team. * Shaping the healthcare product roadmap: Working hand-in-hand with the PM and product team on healthcare-required initiatives, from ongoing clinical evaluations to integrations with NHS EPR systems. * Being the subject-matter expert: Acting as the go-to authority on clinical status and medical device regulation, training the team, and engaging the MHRA and DHSC to keep a long-term view of likely changes, including international equivalent standards and regulations outside the UK. * Driving operational excellence: Setting a clear roadmap for healthcare operations and compliance initiatives, agreeing priorities and resourcing, and knowing when to bring in external contractors, agencies, or new hires. * Keeping everyone aligned: Making sure every team that interfaces with this role – Commercial, Product, Legal, Trust and Safety, Senior Leadership, and our Clinical Safety Officer – has a clear sense of what is happening, when, why, and who owns it. You are * A Compliance Manager with experience owning clinical compliance and regulation roadmap (Medical Device Classifications; DCB docs), including driving Class IIa medical device regulation. * An expert in working with PMs on healthcare-required product roadmaps (e.g. ongoing clinical evaluations; integrations with NHS EPR systems; etc.). * A skilled project manager in complex, multi-functional environments related to compliance - coordinating across teams to deliver at pace. * A Detail-Oriented Operator: You have a sharp eye for detail and take pride in getting complex regulatory work exactly right, with precision and consistency. * A Reliable Independent Worker: You are a dependable executor who just gets the job done. You don't need constant hand-holding, but you are also a fantastic, collaborative teammate. * Technically Curious: You are comfortable talking about products and AI, eager to learn how data flows across our infrastructure, and able to work closely with product and engineering on integrations. * A Clear Communicator: You effortlessly engage stakeholders, break down regulatory nuance, and are an active, empathetic listener - confident and credible in customer-facing situations. * Commercially Minded and Driven: You understand that a lot of the compliance roadmap will be shaped by commercial priorities, and you build and drive team momentum. ABOUT BEAM Our team of 200+ embraces a hybrid working approach, enjoying 2-3 days of vibrant collaboration in our beautiful Shoreditch co-working space, fully equipped with rooftop views, an onsite barista and kitted out gym. We’ve picked up an armful of awards for our work, including one from our former Queen. We've also been named by WIRED as one of London's 10 hottest startups and by LinkedIn as a Top 15 UK Startup. Meanwhile, we've been covered in the media literally thousands of times, including the likes of The FT, BBC, TechCrunch, Forbes and The Guardian. We’re also proud to be backed by some of the world's leading tech investors and entrepreneurs, including the founders of Booking.com, Calm, Shazam and Dropbox. Start your journey to a more impactful career today. We're excited to hear from you. Reasonable adjustments: Beam is committed to fostering an inclusive, diverse, and supportive work environment for all employees. This policy extends to our hiring practices. We recognise that some candidates may need additional support during their hiring process to give them the best chance of being a success. To ensure that all candidates have an equitable opportunity during their process, we are committed to providing reasonable adjustments where required. If you require a reasonable adjustment to be made during your process, please let your Talent Partner know. We encourage you to share this information, but there is no obligation to do so. Please be reassured that any reasonable adjustment requests will not be taken into account when making a decision about your candidacy.

Beam

At Beam, you get to do work that matters for the world. We’re solving the world's toughest social problems with an incredible team, tech and AI. And we’re growing fast 🚀 It’s not easy. Nothing worth doing ever is. Join a company at the forefront of social impact, driving first-of-its-kind positive change. You’ll be part of a high-performance culture where you'll make a huge impact, rapidly progress your career, and truly enjoy your work. From top-tier coaching and personal development budgets to competitive salaries, we take care of everyone who works at Beam. We’ve already seen incredible growth from our Beam Notes product, helping frontline workers save over 8 hours of admin per week. From social workers and NHS clinicians to mental health practitioners and safeguarding specialists, nearly 100,000 frontline workers across the UK, US and Australia are now using Beam Notes regularly to deliver faster, more human-centred support. Are you an expert in all things medical device regulation and healthtech, who thrives in high ownership, cross-functional roles? We are looking for a Quality & Regulatory Affairs Lead - Digital Health to own clinical compliance and regulation across our healthcare products. In this highly operational, high-ownership role, you will drive Beam towards Class IIa medical device certification for our products, while being the day-to-day contact for all things cross-functionally healthcare. You will be the guardian of our clinical regulatory status - from DCB documentation and ISO standards through to our quality management system, ongoing clinical evaluations, and our engagement with the MHRA and DHSC. This isn't your typical regulatory role. We're building out a healthcare team and you'll be our detail-oriented "founding generalist" within it, wearing many hats. In a typical week you might: progress a Class IIa submission, shape the healthcare product roadmap with our PM, scope an NHS EPR integration, run a clinical evaluation, train the team on a new process, and bring in external advice exactly where we need it. You'll set the roadmap for our clinical operations and have a clear sense of when to expand or hire in additional resource. We are keen to use AI to automate wherever we can, and we'll encourage you to find efficiencies in how we work, meaning your focus stays on high-accuracy regulatory review, strategic planning, and being the subject-matter expert the whole company can rely on. This is an incredible opportunity to learn the ins and outs of our technical architecture, master the regulatory pathway for AI-enabled medical software, and play a pivotal role in driving rapid growth in the healthcare side of our business. You'll be * Owning clinical compliance and the regulatory roadmap: Taking ownership of medical device classifications and DCB documentation, and driving Class IIa medical device regulation for our products. * Driving certification through to completion: Owning timely audits, compliance, and submissions, while building out the QMS and the processes within the team. * Shaping the healthcare product roadmap: Working hand-in-hand with the PM and product team on healthcare-required initiatives, from ongoing clinical evaluations to integrations with NHS EPR systems. * Being the subject-matter expert: Acting as the go-to authority on clinical status and medical device regulation, training the team, and engaging the MHRA and DHSC to keep a long-term view of likely changes, including international equivalent standards and regulations outside the UK. * Driving operational excellence: Setting a clear roadmap for healthcare operations and compliance initiatives, agreeing priorities and resourcing, and knowing when to bring in external contractors, agencies, or new hires. * Keeping everyone aligned: Making sure every team that interfaces with this role – Commercial, Product, Legal, Trust and Safety, Senior Leadership, and our Clinical Safety Officer – has a clear sense of what is happening, when, why, and who owns it. You are * A Compliance Manager with experience owning clinical compliance and regulation roadmap (Medical Device Classifications; DCB docs), including driving Class IIa medical device regulation. * An expert in working with PMs on healthcare-required product roadmaps (e.g. ongoing clinical evaluations; integrations with NHS EPR systems; etc.). * A skilled project manager in complex, multi-functional environments related to compliance - coordinating across teams to deliver at pace. * A Detail-Oriented Operator: You have a sharp eye for detail and take pride in getting complex regulatory work exactly right, with precision and consistency. * A Reliable Independent Worker: You are a dependable executor who just gets the job done. You don't need constant hand-holding, but you are also a fantastic, collaborative teammate. * Technically Curious: You are comfortable talking about products and AI, eager to learn how data flows across our infrastructure, and able to work closely with product and engineering on integrations. * A Clear Communicator: You effortlessly engage stakeholders, break down regulatory nuance, and are an active, empathetic listener - confident and credible in customer-facing situations. * Commercially Minded and Driven: You understand that a lot of the compliance roadmap will be shaped by commercial priorities, and you build and drive team momentum. ABOUT BEAM Our team of 200+ embraces a hybrid working approach, enjoying 2-3 days of vibrant collaboration in our beautiful Shoreditch co-working space, fully equipped with rooftop views, an onsite barista and kitted out gym. We’ve picked up an armful of awards for our work, including one from our former Queen. We've also been named by WIRED as one of London's 10 hottest startups and by LinkedIn as a Top 15 UK Startup. Meanwhile, we've been covered in the media literally thousands of times, including the likes of The FT, BBC, TechCrunch, Forbes and The Guardian. We’re also proud to be backed by some of the world's leading tech investors and entrepreneurs, including the founders of Booking.com, Calm, Shazam and Dropbox. Start your journey to a more impactful career today. We're excited to hear from you. Reasonable adjustments: Beam is committed to fostering an inclusive, diverse, and supportive work environment for all employees. This policy extends to our hiring practices. We recognise that some candidates may need additional support during their hiring process to give them the best chance of being a success. To ensure that all candidates have an equitable opportunity during their process, we are committed to providing reasonable adjustments where required. If you require a reasonable adjustment to be made during your process, please let your Talent Partner know. We encourage you to share this information, but there is no obligation to do so. Please be reassured that any reasonable adjustment requests will not be taken into account when making a decision about your candidacy.