Company DescriptionEMA Aesthetics Ltd. is an Irish company (established in 2019) specialising in medical and aesthetic devices, as well as professional skincare products. Our portfolio is marketed globally under the Préime brand—derived from the Irish "Préimhe," meaning premium. Our flagship product lines include Préime DermaFacial, Préime DermaCeuticals, and Préime DermaProfessional.We pride ourselves on the efficacy of our offerings and have secured leading intellectual property in both device technology and regenerative therapies. Our approach emphasises Combination Therapy, enhancing the utility of our products either as standalone treatments or in conjunction with other aesthetic procedures. Our channels to market include both sub-distributors and direct sales operations, supplying clinics, medspas, doctors, and skincare professionals.Since our inception, we have formed strategic partnerships with Sinclair Pharmaceuticals, Merz Aesthetics, and Rohto Pharmaceuticals. Our global distribution footprint spans 60+ countries, supported by subsidiaries in Belgium, Dubai, and the United States.We are an ISO 13485 and MDSAP-certified organisation with an actively embedded Quality Management System across our operations. Our QMS policy focuses on continual improvement and on achieving high levels of user, client, and customer satisfaction throughout the organisation.Role DescriptionEMA Aesthetics Ltd. is seeking a Quality & Regulatory Officer to support the maintenance, effectiveness, and continuous improvement of its ISO 13485 & MDSAP-certified Quality Management System and global regulatory portfolio.This is a hands-on QA/RA hybrid role suited to an experienced professional who is comfortable operating independently in a fast-scaling, international medical aesthetics organisation. Operating across 60+ countries, the role plays a central part in safeguarding product quality, regulatory compliance, and global market access.The position is fully remote, with occasional international travel (estimated 5–10%) to support audits, suppliers, and regulatory activities.Key Responsibilities:1. Quality Management System & AuditsMaintain and improve the ISO 13485 & MDSAP-compliant QMS.Support internal audits, supplier audits, and external notified body and regulatory inspections.Manage and support CAPAs, nonconformances, deviations, and root cause analyses.Review and approve controlled documentation, including SOPs, work instructions, and technical files.Collaborate with contract manufacturers and critical suppliers to ensure alignment with QMS requirements.Support risk management activities in accordance with ISO 14971, including risk documentation, analysis, and mitigation tracking.2. Post-Market Surveillance (PMS)Perform global PMS activities, including complaint handling, trend analysis, vigilance assessment, and regulatory reporting.Maintain PMS documentation for both medical devices and cosmetic products.Support the preparation and maintenance of PMS Plans, PMS Reports, PSURs, and SSCPs (where required).Support safety evaluations and risk–benefit assessments based on real-world data.3. Regulatory Affairs & Market MaintenanceSupport the preparation, submission, and maintenance of global regulatory filings, including FDA 510(k), Health Canada MDL, ARTG applications, EU technical documentation, and selected ROW dossiers.Maintain country-specific registrations, certifications, and licences across 60+ global markets.Monitor global regulatory developments and assess their impact on EMA's product portfolio.Support product classification, regulatory strategy discussions, and technical assessments for new products or modifications.Assist in preparing regulatory documentation for distributors, tenders, notified bodies, and regulatory authorities.4. Documentation & Cross-Functional SupportMaintain technical documentation for medical and aesthetic devices in line with global regulatory expectations.Support global labelling and IFU compliance, including region-specific requirements.Support distributor onboarding, quality agreements, and regulatory due diligence.Collaborate cross-functionally with R&D, Supply Chain, Marketing, Clinical, and Commercial teams.Provide internal training on QMS and regulatory topics, as requiredQualificationsBachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related scientific discipline.Minimum 4 years' hands-on experience in Quality Assurance and Regulatory Affairs within a regulated medical device, aesthetics, cosmetics, or life sciences environment.Strong working knowledge of ISO 13485 and MDSAP-compliant QMS environments.Experience supporting PMS, complaint handling, risk management, and technical documentation.Familiarity with global regulatory frameworks, including FDA, Health Canada, TGA, and EU MDR principles.Strong technical writing and documentation skills.Fluency in English (spoken and written); additional languages are an advantage.PreferredExperience within medical aesthetics or regenerative skincare.Exposure to FDA 510(k) submissions or equivalent regulatory pathways.Understanding of cosmetic regulatory frameworks across multiple regions.Professional certifications such as RAC, ISO 13485 Lead Auditor, or equivalent.Preferred Behavioural Attributes:· Meticulous attention to detail with strong documentation discipline.· Proactive and accountable, with the ability to independently drive tasks to completion.· Comfortable working autonomously within a remote, globally distributed team.· Adaptable and agile in a fast-paced, scaling organisation.· Strong analytical capability for trending, metrics, and regulatory reporting.Why work for EMA Aesthetics?EMA Aesthetics offers the opportunity to be part of a globally expanding medical aesthetics organisation where quality, regulatory excellence, and scientific credibility underpin commercial success. With products distributed across more than 60 international markets and continued growth planned through 2026, the organisation is entering a critical phase of scale and operational maturity.This role sits at the centre of that evolution, providing exposure to global regulatory systems, complex supply chains, and cross-functional decision-making. You will join an internationally distributed team of approximately 30 professionals that values autonomy, accountability, and execution, and where regulatory and quality functions are recognised as strategic enablers of sustainable growth.For the right candidate, this is a gateway opportunity to a high-growth company on a clear trajectory of success. EMA Aesthetics is a modern, agile organisation with a strong strategic focus and a commitment to excellence.