Director of Research and Development

1 month ago


Bath, Bath and North East Somerset, United Kingdom Mackinnon Bruce International Full time
About the Role

Mackinnon Bruce International is seeking an experienced R&D Director to lead the development and commercialization of our pioneering diagnostic system. As a key member of our team, 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.


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