Regulatory and Quality Manager Full Time

Position SummaryThe Regulatory and Quality Manager is responsible for leading and managing all regulatory affairs and quality assurance activities for Topia Medtech Limited. The role ensures that the company’s medical devices and related products comply with applicable UK, EU, and international regulatory requirements and quality standards.The individual will develop regulatory strategies, prepare and manage submissions, coordinate approvals with regulatory authorities, maintain the Quality Management System (QMS), and support post-market compliance activities.Key Responsibilities1. Regulatory Strategy & ComplianceDevelop and implement regulatory strategies for medical devices in the UK, EU, and other international markets.Interpret and apply regulatory requirements including:UK MDR 2002 (as amended)EU MDR 2017/745ISO 13485MHRA guidanceRelevant IEC/ISO standardsProvide regulatory guidance during product development and commercialization.Assess regulatory pathways and classification of medical devices.Ensure ongoing compliance with regulatory requirements and industry standards.Monitor changes in global regulatory regulations and communicate impacts to management.2. Regulatory Submissions & ApprovalsPrepare, review, and submit regulatory submissions to authorities including:MHRA (UK)EU Notified BodiesInternational regulatory agencies where applicableCompile and maintain technical documentation including:Technical FilesDesign DossiersClinical Evaluation Reports (CER)Risk Management FilesPost-Market Surveillance documentationCoordinate product registrations, renewals, amendments, and approvals.Act as primary liaison with regulatory authorities and notified bodies.Manage responses to regulatory queries and deficiency letters.Support UKCA and CE marking activities.3. Quality Management System (QMS)Establish, maintain, and improve the Quality Management System in compliance with ISO 13485.Ensure implementation of quality procedures, SOPs, and policies.Lead internal audits and support external audits and inspections.Manage CAPA (Corrective and Preventive Actions), deviations, non-conformities, and change control processes.Ensure document control and record management systems are maintained.Promote quality culture across the organization.4. Product Lifecycle & Post-Market ActivitiesSupport product lifecycle management from development through commercialization.Oversee Post-Market Surveillance (PMS) and vigilance reporting activities.Ensure timely reporting of adverse events and field safety corrective actions.Coordinate periodic safety updates and trend reporting.Review product labeling, IFUs, and promotional materials for regulatory compliance.5. Cross-Functional CollaborationCollaborate with R&D, manufacturing, clinical, marketing, and supply chain teams.Provide regulatory input for design control and risk management activities.Support supplier qualification and quality agreements.Train employees on regulatory and quality requirements.6. Leadership & Continuous ImprovementLead quality and regulatory projects and initiatives.Drive continuous improvement activities within the QMS.Maintain inspection readiness at all times.Support business growth through timely regulatory approvals and market access strategies.Qualifications & ExperienceEducationBachelor’s degree in:Regulatory AffairsBiomedical EngineeringLife SciencesPharmacyQuality ManagementOr related disciplineMaster’s degree preferred.ExperienceMinimum 5–8 years’ experience in Regulatory Affairs and Quality Assurance within the medical device industry.Strong experience with:UKCA markingCE markingMHRA submissionsEU MDRISO 13485Experience interacting with regulatory authorities and notified bodies.Knowledge of clinical evaluation and risk management processes.Experience managing audits and inspections.Skills & CompetenciesStrong knowledge of medical device regulations and standards.Excellent technical writing and documentation skills.Strong analytical and problem-solving abilities.Effective communication and stakeholder management skills.Ability to manage multiple projects and deadlines.Leadership and team management capability.High attention to detail and organizational skills.Key Performance Indicators (KPIs)Timely submission and approval of regulatory applications.Successful maintenance of ISO 13485 certification.Audit and inspection readiness.Reduction in non-conformities and CAPAs.Compliance with regulatory timelines and reporting obligations.Successful product registrations and renewals.Regulatory Authorities & Standards ExposureMHRA (Medicines and Healthcare products Regulatory Agency)UK MDR 2002EU MDR 2017/745ISO 13485ISO 14971IEC 60601 (where applicable)FDA (desirable)International regulatory frameworks (desirable)Additional Responsibilities (Optional Depending on Company Size)Acting as UK Responsible Person (UKRP) liaison.Supporting distributor and importer compliance.Managing external regulatory consultants.Participating in management review meetings.Supporting business development with regulatory intelligence.