Director of Research Development

Mackinnon Bruce is partnered with an innovative IVD start-up developing a disruptive POC test to help rapidly increase the speed of diagnosis for infectious diseases to ensure that patients can receive the correct treatment in as little as an hour. Our client has a key focus on radically transforming the way bacterial infections are diagnosed to drastically improve patient care, reduce human suffering, and reduce antimicrobial resistance (AMR). We are developing a rapid, point-of-care, urinary tract infection diagnostic which takes 60 minutes versus the multi-day wait it currently takes. We are seeking an experienced R&D Director to lead the development and commercialization of our pioneering diagnostic system. You will play a pivotal role in driving the integration of benchtop assays into custom disposables and instruments, overseeing non-clinical performance testing, and ensuring product approvals meet all quality, regulatory, and performance standards. Responsibilities: Lead the integration of benchtop assays into disposable prototypes and instrumentation. Manage non-clinical performance testing, ensuring compliance with timelines, budgets, and quality/regulatory standards. Oversee the preparation and presentation of analytical data for product approvals. Support and manage quality procedures in line with ISO 13485 and other regulatory standards. Manage internal and external audits. Set up and refine laboratory processes to meet best practice and regulatory standards. Lead and mentor a lab team across two locations, ensuring projects are delivered efficiently and aligned with business goals. Drive the development and integration of new technologies and methodologies to enhance our IVD capabilities. Requirements: 15-20 years of industrial R&D experience, with a background in medical laboratory practices. BSc/MSc/PhD in Microbiology, Biology, Molecular Biology, Biochemistry, or a related field. Extensive experience in POC/IVD industry, with a proven track record in R&D leadership. In-depth knowledge of ISO 13485, IVDR, and other quality/regulatory standards. Demonstrable experience in developing products from concept to commercialization, including the preparation of analytical data for regulatory submissions. Strong leadership skills with the ability to manage cross-functional teams and ensure projects meet timelines, budgets, and quality requirements. What We Offer: A hybrid work model with 2-3 days onsite. Opportunity to lead a passionate team in a high-impact, mission-driven company. Competitive industry salary and benefits, including Private Medical Insurance, enhanced pension contributions, and optical/dental support. If you are interested in learning more about this position then feel free to send an email to ben.birkheadmackinnon-bruce.com or apply below and I will be happy to answer any questions you may have.