Building on 30 years of experience in transfusion diagnostics, AliveDx is committed to delivering solutions that reshape the way diagnostics is practiced. AliveDx has two key product portfolios, Alba by Quotient and MosaiQ by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. AliveDx operations are based in Eysins, Switzerland, Edinburgh, Scotland and Chicago, Illinois. Department leader, REGULATORY AFFAIR SWe are recruiting for a Department Leader to join our Regulatory Affairs Team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday .The Department Leader for Regulatory Affairs is responsible for the initial registration of new products and for ensuring the continued registration for all Alba products after initial registration or approval, by liaising with regulatory bodies to address compliance issues and to provide this information to the appropriate staff groups. JOB DESCRIPTI ONThe main responsibilities will includ e: Serve as a member of the Regulatory and Quality Management Team for oversight and guidance of the entire organisation on RA and Quality strategy and activit iesEnsure that technical documentation and the EU declaration of conformity of the devices for which Alba Bioscience Ltd is the legal manufacturer are drawn up and kept up to d ateManage, prepare and maintain regulatory documentation to enable the Company to comply with ISO13485 standard and to ensure regulatory compliance with the 98/79/EC IVD Directive (IVDD), Regulation (EU) 2017/746 (IVDR), FDA Code of Federal Regulations and Canadian Medical Device Regulations, Part 1 as well as regulations required for rest of world submissio ns.Interpret complex legislation and provide expert advice to Alba Management and all staff on all aspects of US FDA, European and worldwide Regulatory Legislation relevant to Alba activities and collaborative undertakings with external organisati onsAssist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), ISO13485 standard, the 98/79/EC IVD Directive, Regulation (EU) 2017/746 (IVDR), FDA Regulations, Health Canada Medical Device Regulation, Part 1 (SOR/98-2 82)Lead in the management, planning, coordination, preparation and interpretation of relevant information necessary for product license applications to ensure successful granting, maintenance and development of such licenses by the FDA including but not limited to BLA, 510(k) and PMA submissions for immunohaematology reagen ts.Compile and submit initial registration/approval submissions in international markets post initial submission in EU, USA and other large territor iesCompile product information for the preparation of technical files and regulatory dossiers to support product license applications and product license maintenance for worldwide Regulatory Authorit iesReview analytical data from laboratory processes, clinical field trials and product evaluation data to support product registration and license applicati onsAdvise Alba staff on data and information required for successful license applications and registrations and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submiss ion QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQU IREDArelevant degree or professional qualification and extensive experience in a regulatory affairs environm ent.Extensive experience of filing US regulatory applications (BLA, 510(k), PMA submissions) and EU CE marking (IVDD/IVDR) applicati ons.Extensive post-market experience ensuring ongoing regulatory compliance Data analysis and interpretation ski lls.Significant specialist knowledge of regulatory affairs as applied to in v itro diagnostic medicaldevices and an understanding of the operation of a medical device manufacturing establish mentPrevious department management experience with strong leadership skills to manage a team. High sense of responsibility and accountability to ensure compliance and to insp ire. ADDITIONAL INFORM ATIONCompetitive salary on o ffer.AliveDx offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant disco unts.