Regulatory Compliance Specialist
hace 3 días
Letchworth
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.
