Select jobs in BelfastCrear alertas

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 company’s core values. • Support the work of the company and project teams in the provision of specialised regulatory and quality assurance expertise to client companies, ensuring client expectations and interests are met., • Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to 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 worldwide., • Manage and keep up to date information relating to regulatory requirements for IVD performance studies and maintain the company’s web-based clinical trial planning tool., • Conduct gap analyses on behalf of client companies and prepare associated reports, • 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., • 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 “We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”

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 Purpose As a AI Software Engineer, you will play a key role in designing, developing and maintaining high performance cloud-based applications. You'll work with cutting-edge Azure technologies to support our mission in precision medicine research. You will be a vital link between the software team and Internal & external stakeholders. Key Responsibilities • Develop & maintain applications using .NET (C#), .NET Core, and Azure technologies., • Collaborate with product managers, designers, and developers to create high-quality software solutions., • Develop AI solutions in a regulated environment, ensuring adherence to AI governance and compliance frameworks., • Design and implement Retrieval-Augmented Generation (RAG) architectures to optimize information retrieval for LLMs., • Mentor junior members of the development team, providing expert support when required., • Contribute to design decisions for up-and-coming projects, • Become a vital link between the software team and key internal and external stakeholders., • Design and manage MS SQL Server databases, optimizing performance and scalability., • Implement Azure cloud services (App Services, Functions, Storage, DevOps)., • Participate in code reviews and contribute to software development best practices., • Troubleshoot and debug applications to ensure reliability and efficiency., • Stay up to date with emerging technologies and industry trends. Essential Skills & Experience • Minimum of 3 years’ experience within a Senior Software Developer role, • Minimum of 5 years post graduate experience within Software Development, • Degree in computer science of a related discipline, • Strong experience in .NET (C#, .NET Core) and SQL Server., • Proficiency in Azure cloud services (Azure App Services, Functions, Storage)., • Experience with front-end technologies (HTML, CSS, JavaScript, Angular, React)., • Experience with latest AI technologies, • Understanding of microservices architecture & API development., • Strong problem-solving and debugging skills., • Previous experience in mentoring junior members of staff. Desirable Skills • Experience with Azure DevSecOps & CI/CD pipelines., • Strong communication and teamwork skills., • A keen interest in AI, • Some experience with PHP and symphony, Why Join ARC Regulatory? • Competitive Salary, • 30 days of annual leave, increasing to 35 days over time, • Employer pension contributions, • Employee Benefits Program (after probation), • Hybrid working model (3 days after the first 12 weeks of employment), • Training budget for professional development, • Office located in Catalyst Belfast – a hub of innovation “We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”

At TSR Select, we value a strong work ethic and a genuine passion for success in every role. TSR Select is a specialist recruitment consultancy working in the Cloud, Cyber and Managed Services spaces. At TSR Select, we are a growing recruitment consultancy with a reputation for delivering on our pro

London | £26,000 - £30,000 | Permanent.Hours: Full-time, office-based (5 days per week).Monday – Thursday: 2 days 11:00 am – 19:00, 2 days 10:00 – 18:00.We are looking for a highly organised and detail-oriented Post Sales Administrator to support a busy team in the heart of the City.This is

Senior SAP Payroll / SuccessFactors ECP Consultant | UK (Fully Remote) | £60,000 - £100,000 (DOE).We are working with a global HR and Payroll consulting specialist that partners with enterprise clients to deliver complex SAP and SuccessFactors solutions across multiple industries.Due to continued

Executive Assistant / 3-month contract position / London, Hybrid / Up to £270 per day (Umbrella rate).My client, a globally recognised organisation are currently looking for a Executive Assistant to join their Team.The role will require an organised, personable and detail orientated individual who

Application Packaging & Deployment Engineer - £50,000 – £60,000 (pro rata) - 6-Month FTC (likely extension) – Have to be eligible for UK Security Clearance – IT Managed Services Firm.Our client, a leading IT Managed Services Provider, is seeking an experienced Application Packaging & Deploym

The Collection Strategy Manager leads the design, implementation, and optimisation of strategies and configuration across ORCA, EDGE, and SQL-based configuration packages.The role is responsible for ensuring that all strategies deliver measurable performance improvements, align with client requireme

Recruitment Coordinator / London / Hybrid / Contract.An excellent opportunity has arisen with a global brand for a detail-oriented Recruitment Scheduler to support an established talent acquisition team during a period of growth.The Recruitment Scheduler will be responsible for coordinating intervie

Line Support Analyst - £180 - £200 per day – Initial 3 Month contract (Inside IR35) – 5 days onsite (Based in London) - Government Organisation.We are seeking an experienced 1st/2nd Line Support Analyst to join our dynamic IT team.This role is ideal for someone with a strong technical backgrou

Employee Relations Specialist / Up to £350 per day (Umbrella Rate) / London / Hybrid / 4-month contract position.A leading organisation are currently seeking a Employee Relations Specialist to manage multiple ER cases at one time and support the organization with structural changes.This is an excel

PMO Consultant | £750 p/d Inside IR35 | London Hybrid.Our client is seeking an experienced PMO Consultant to provide expert guidance and support across their programme and project management function.The role focuses on strengthening PMO capability, enhancing governance, improving reporting, and dr

A respected and well-established insurance provider is seeking a driven Customer Sales Executive to join their expanding team in Taunton.This is a fantastic opportunity for someone with customer service or sales experience to build a rewarding career in the insurance sector, with clear progression o

Senior SAP Payroll / SuccessFactors ECP Consultant | UK (Fully Remote) | £60,000 - £100,000 (DOE).We are working with a global HR and Payroll consulting specialist that partners with enterprise clients to deliver complex SAP and SuccessFactors solutions across multiple industries.Due to continued

About TSR Select TSR Select is a specialist recruitment consultancy working in the Cloud, Cyber and Managed Services spaces. What TSR Select Offers You At TSR Select, we are a growing recruitment consultancy with a reputation for

Senior Customer Service Executive | £40,000 - £43,000 | East London.My client, a leading organisation within the property sector, is seeking a Senior Customer Service Executive to join their busy team on a permanent basis.This is a hands-on coordination role with supervisory responsibilities, supp

At TSR Select, we value a strong work ethic and a genuine passion for success in every role. TSR Select is a specialist recruitment consultancy working in the Cloud, Cyber and Managed Services spaces. At TSR Select, we are a growing recruitment consultancy with a reputation for delivering on our pro

Underwriting Operations Manager (12-month Contract) | £1,000 per day (umbrella) | London (Hybrid).A leading insurance organisation is seeking an experienced Underwriting Operations Manager to oversee end-to-end underwriting processes and drive operational efficiency across the business.Manage the f

Conference Producer / Hybrid / London / £50,000 base plus bonus.A fast-growing events and intelligence business is seeking a Conference Producer to join its Financial Services and Technology portfolio.This role sits within a high-performing content team responsible for delivering market-leading con

Senior Marketing Planning Manager / Contract / £550 per day / London.We’re looking for a strategic, insight-driven Senior Marketing Planning Manager to lead marketing planning, campaign direction and performance across our organisation.You’ll shape annual and quarterly marketing plans, champion