Senior Regulatory Affairs Specialist - MedTech A growing MedTech company is seeking an experienced Senior/Lead Regulatory Affairs Specialist. The ideal candidate will act as the key liaison between the business, its products, and regulatory bodies, with responsibility across pre- and post-market regulatory activities. Were looking for someone with strong experience in Medical Devices/Technology regulatory frameworks (including FDA submissions and international standards) who can guide products from development through to market launch and beyond. Key responsibilities: Provide regulatory guidance to internal teams and senior management, supporting the preparation and submission of regulatory documentation. Maintain and update regulatory files and tracking systems to ensure timely access to approval and renewal information. Ensure products comply with regional and international regulations and standards. Keep abreast of evolving legislation, guidelines and industry practices. Analyse and present scientific data to support new product approvals and renewals. Manage submission timelines for licence variations and renewals, ensuring deadlines are met. Prepare and review product labels, patient information leaflets and related documentation. Advise on product testing requirements and interpret clinical and technical data. Offer strategic regulatory input during product development and updates. Lead or coordinate regulatory inspections and audits. Liaise and negotiate with regulatory authorities to secure product authorisations. Support process improvements and provide compliance training and advice to teams. About You: Strong industry experience operating in a Senior/Lead level role within Regulatory Affairs. Experience working with Medical Devices/Technology in a regulated environment; Class IIa devices and above. Experienced in FDA 510(k) submissions. Wider experience in 60601-1 and SaMD would be beneficial. Proven ability to manage regulatory processes, leading Class IIa device accreditation with regulators. Collaborative, organised and able to manage multiple projects and deadlines. This role is a hybrid role with working in the Cambridge based office for 1-2 days per week and the remainder from home. We are unable to consider candidates seeking a remote role or less frequency in the office.