Senior Specialist- Regulatory Affairs

ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients. We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial. ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable. To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials. Job Description To be an integral member and significant contributor to project team(s) in the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to regulatory research, internal and external stakeholder satisfaction as well as an innate work ethic and attention to detail that is aligned with the companys core values. Support the work of the company and project teams in the provision of specialised regulatory expertise to client companies, ensuring that internal procedures and client expectations and interests are met. Bring considerable experience in IVD/CDx development, validation and approval to client organisations, providing expert strategies and guidance to their development programmes. Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc. Assist wider team in understanding the regulatory requirements for an investigational device in the set-up, management & conduct of IVD performance studies/clinical investigations worldwide (e.g. IVDR and 21 CFR 812 requirements). Manage and keep up to date information relating to global regulatory requirements for IVD devices and maintain the companys web-based clinical trial planning tool. Conduct gap analyses on behalf of client companies and prepare associated reports (e.g. technical documentation/design history files). Contribute to the preparation of global guidance documents and white papers. Contribute to the preparation of other regulatory documents on behalf of client companies (e.g., Performance Evaluation Plans/Reports, Investigator Brochures, etc). As required, take advantage of professional networking opportunities to promote the company and its services to appropriate parties. Design and deliver formal client presentations, including proposed solutions and client training. Prepare and deliver presentation(s) relevant to the companys regulatory support offerings at industry meetings and conferences. Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards. Contribute to ARC company culture initiatives to maintain a positive and engaging workforce. Any other duties, within reason and capability, as determined by company management. Essential Criteria Engineering or Scientific honours degree or equivalent (10+ years) relevant industry experience 5+ years experience of working in a medical device/IVD manufacturing or regulatory environment Experience with IVD/CDx design and development, from feasibility to approval Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices (e.g. EU/US) Experience of leading global regulatory submissions (e.g. EU/FDA) Experience developing and maintaining technical documentation (IVDD/IVDR) or design history file documentation (FDA) Experience developing global regulatory strategies for IVD devices Skills: Regulatory Affairs IVDR CDx