Regulatory Affairs Officer

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life. REGULATORY AFFAIRS OFFICER AliveDx are recruiting a Regulatory Affairs Officer to join the Regulatory Affairs team based near Edinburgh (EH26 0BF). The role is responsible for building regulatory strategy, to determine applicable regulatory requirements, propose solutions to comply with regulatory requirements and manage product license registration with the appropriate regulatory authorities worldwide. Furthermore, the role is responsible for providing guidance to the company on regulatory requirements and aspects. YOUR MISSION Your main responsibilities will include: Advise AliveDx staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission. Prepare and compile regulatory documentation, coordinate and execute regulatory submission for countries including US, EU, Canada and any other territories as appropriate in compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate. Develop product labelling regulatory requirements for AliveDx products and for customer contracted products including but not limited to package labels, product labels and instructions for use. Liaise with internal and external parties as required to support development of product labelling. Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards. Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs) Biologics License Applications (BLA), Medical Device Approvals (510(k), Canadian Medical Device Regulations (CMDR) – Part 1 and other non-registered product requirements to support compliance for Quotient and its products. Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information. Ensure that changes are documented in accordance with quality system requirements and are communicated on a timely basis, as appropriate, to the Regulatory Authorities. YOUR COMPETENCIES A relevant degree and/or relevant work experience in a regulatory affairs environment. Experience in medical device/IVD/Biotech industry Experienced in meeting with, making presentations to, and negotiating with regulators Previous experience preparing and submitting BLA, 510(k), PMA, CE mark and technical files to other worldwide regulatory authorities. Great attention to detail, communication and collaboration skills. WHAT WE OFFER A highly dynamic and growing environment. An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do. A flexible working environment where applicable and a range of core and flexible benefits ranging from pension, private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts. Interested ? We look forward to receiving your application. AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.