Key areas of responsibility include regulatory/technical file maintenance and new registrations and process validation/project management with some overlap with Quality functions such as quality assurance and quality auditing. Reporting to the CEO and Quality Director (PRRC), the role will work closely with other roles across the business and external service providers.Key Duties & Responsibilities:Regulatory Affairs:Maintains and organises appropriate regulatory records (technical files and product files) to demonstrate compliance with applicable regulations (ISO13485/EU Medical Device Regulations 2017/475Track registrations, variations and Health Authority Commitments, related to company products and maintaining company regulatory databases for registrations, variations and commitments.Obtaining information and keeping up to date on regulatory compliance and guidelines prepared by National Regulatory Agencies and Notified Bodies.Processing queries from distributors on regulatory matters and supporting them where possible.Create, provide input to and execution of regulatory strategies related to existing and new medical device licences.Preparing and submitting new medical device submissions, associated packaging and translation across multiple territories using most appropriate route.Preparing and managing international regulatory submissions and artwork management in accordance with commercialisation plan.Plans and prepares regulatory submissions for medical devices and foods for specific target markets for new products, product changes and re-registrations as required.Maintains registration information (authorisation numbers, expiration dates etc) and obtains re-registration approvals in advance of product or certification expirations to ensure no disruption in product availability.Ensure that business continues to operate in accordance with European food products, the Medical Device Directive/Regulations and ISO regulations for medical devices and any other relevant guidelines related to company business.Preparation and updating of company SOPs.Assist with the preparation of Technical Agreements with all relevant suppliers.Maintaining and coordinating systems relating to RA/QA, including change control, deviations, CAPA, complaints, audits and vendor approval.Assist with the preparation of the Quality Management Reviews and Product Quality Review.Assist with preparation for Health/ Competent Authority and Notified Body inspections and prepare regulatory inspection responses.Participate and where appropriate led Innovation and continuous improvement projectsVigilance activities such as vigilance and compliant trending, post marketing surveillance, post marketing surveillance plans and PSUR generationMonitoring and appropriate updates to regulatory portalsOther duties and responsibilities may be assigned with reasonable notice.