QARA Professional

About Ellele HealthEllele Health is a wholly owned subsidiary within The Origin Group Limited (TOGL). Ellele Health is a medical research company dedicated to transforming women's health. The company has developed a novel sampling medical device to support early detection and management of critical conditions like endometrial cancer.Role OverviewWe are seeking a motivated and experienced Quality and Regulatory Affairs professional to support our ongoing commitment to excellence and regulatory compliance. This role focuses on maintaining and evolving our ISO 13485‑compliant QMS, supporting the initial ISO certification process, generating and managing technical documentation, and overseeing all areas of regulatory affairs. The position offers flexibility and can be structured on a part‑time basis, depending on the right candidate.Key ResponsibilitiesMaintain, evolve, and ensure compliance of the QMS to ISO 13485 and drive the preparation and successful achievement of ISO 13485 certification.Prepare, document, and implement policies and procedures.Lead and coordinate internal audits, supplier audits, management reviews, and continuous improvement initiatives.Ensure compliance with UK MDR and EU MDR.Lead all post‑marketing activities in line with quality and regulatory requirements under UK MDR, EU MDR, and ISO 13485.Act as the PRRC.Develop, manage, and maintain technical documentation and DHFs in accordance with EU MDR and UK MDR requirements.Have past experience in clinical investigations for medical devices, including preparing required documentation.Oversee regulatory and quality compliance during clinical investigations, ensuring proper processes, documentation, and reporting are in place.Manage all post‑clinical investigation activities, including reporting, data handling, and updates to technical files and regulatory submissions.Monitor and interpret changes in relevant regulations and standards.Advise the leadership team on quality and regulatory implications for new and existing products.Serve as the primary contact for external auditors and regulatory authorities.Ensure training, communication, and awareness of quality and regulatory requirements across the team.RequirementsProven experience working with medical devices and procedure packs. Experience in Class I medical devices under UK and European regulatory frameworks.Strong working knowledge of ISO 13485 with direct experience in implementation and/or maintenance.Ability to manage a QMS independently and confidently.Up‑to‑date understanding of both UK and European medical device regulations.Good working knowledge of harmonised standards, such as ISO 14971, ISO 14155, ISO 10993 and IEC 62366‑1.Strong organisational, communication, and problem‑solving skills.Ability to work flexibly and independently in a small, fast‑paced organisation.Can‑do attitude, with no task too large or too small.Nice to HaveWorking in a start‑up environment.Knowledge regarding RoW and US regulations.BenefitsJoin We are a mission‑driven group innovating in both gastrointestinal and women's health diagnostics. Unique opportunity to contribute across two pioneering clinical pipelines. Collaborative, forward‑thinking environment within a high‑growth company. Competitive salary, benefits, and opportunities for advancement. #J-18808-Ljbffr