Cure Talent Ltd

Cure Talent are delighted to be partnered with an established and growing medical device distributor as they introduce their first dedicated regulatory compliance role. This is a newly created position within an SME environment, offering genuine flexibility to shape the role around the right individual. As the new Regulatory Compliance Specialist, you will take ownership of distributor and supplier regulatory compliance across the product portfolio. Although the business is not the legal manufacturer, this role will be accountable for ensuring that all products placed on the market meet MDR and UK regulatory requirements, working directly with manufacturers and suppliers to manage compliance assurance and regulatory risk. This is a hands on regulatory compliance role, firmly aligned to distributor and economic operator responsibilities. The successful individual will sit at the interface between suppliers, customers, and internal commercial teams, ensuring regulatory compliance does not become a barrier to product supply or market access. Alongside core regulatory compliance activities, there is longer term scope to support the evolution of the management system as the business evaluates a transition beyond ISO 9001. Key responsibilities Lead distributor regulatory compliance activities in line with MDR, UK regulations, and applicable MHRA requirements. Act as the primary point of contact for regulatory compliance with manufacturers and suppliers, including confirmation of conformity, review of regulatory documentation, and ongoing supplier compliance monitoring. Ensure products are supported by appropriate declarations, labelling, instructions for use, and compliance documentation prior to placement on the market. Identify, assess, and manage regulatory compliance risks arising from suppliers, documentation gaps, or regulatory change. Manage customer and internal regulatory compliance queries, providing clear, pragmatic guidance from a distributor perspective. Support distributor relevant post market activities, including complaint coordination, escalation to legal manufacturers, and vigilance related communications where applicable. Maintain regulatory compliance records and procedures relevant to the distributor role, including supplier and product documentation control. Contribute to the evaluation and potential transition towards ISO 13485 and other relevant standards, where appropriate. Monitor changes to MDR, UK regulations, and guidance, advising the business on impact to distributor obligations and product supply. Experience and skills required Experience working in a regulatory, compliance, or RAQA role within the medical device sector, with direct exposure to distributor, importer, or supplier regulatory responsibilities. Strong working knowledge of MDR and UK medical device regulations from an economic operator perspective. Experience managing supplier compliance, including engagement with manufacturers on technical documentation, labelling, and conformity matters. Understanding of management systems, with ISO 9001 experience and exposure to ISO 13485 beneficial. Comfortable operating autonomously in a growing SME environment, with a pragmatic and commercially aware approach.

Cure Talent are delighted to be partnered with an emerging wearable medical technology company at a defining stage of its growth. Developing next generation optical monitoring solutions designed to deliver medical grade physiological insights beyond the hospital environment, the business is now transitioning from research and development into industrialisation and regulated market entry. We have an opportunity for a Head of Product Development to join the organisation at a pivotal stage of its journey. Reporting to the Chief Technology Officer, this is a senior technical leadership role responsible for translating clinical and user needs into defined product requirements and overseeing the development of the company s wearable medical device platform. Working closely with clinicians, end users and internal engineering and data science teams, you will lead product definition and guide the development of clinically meaningful monitoring solutions. The role will oversee multidisciplinary development across firmware, electronics, mechanical and software engineering alongside algorithm and data science capability, supporting the transition of prototype technologies into robust clinical grade devices ready for validation and regulatory approval. Key Responsibilities: Engage with clinicians, healthcare professionals and end users to understand clinical workflows and product opportunities. Translate clinical insight into clear product requirements, specifications and development priorities. Lead product development activities across engineering and data science teams covering firmware, electronics, mechanical and software disciplines. Ensure development activities follow structured medical device development processes including design control, risk management and verification activities. Guide the transition of prototype technologies into clinical grade wearable medical devices ready for validation and regulatory approval. Experience and Skills Required: Minimum 10 years experience developing medical devices, ideally including wearable or physiological monitoring technologies. Experience translating clinical or user requirements into product specifications within multidisciplinary engineering environments. Strong understanding of medical device development processes within regulated environments. Understanding of physiological monitoring technologies, signal processing or algorithm driven medical devices. This is a high impact opportunity within a growing wearable MedTech business developing next generation physiological monitoring solutions, suited to a product development leader who enjoys translating complex technology into clinically valuable medical devices.