FluoretiQ is pioneering a rapid diagnostic platform for bacteria identification which will ensure that patients receive the best anti-biotic treatment from day one. For patients, this means faster recovery times and for healthcare providers, this means significant cost savings. FluoretiQ is based at Unit DX in Bristol with easy access to Bristol Temple Meads train station and city centre.
We are now looking for a Senior Development Scientist with a background in diagnostic assay development to oversee our New Product Development. You will join our growing multi-disciplinary R&D team to ensure our revolutionary bacteria identification products are delivered successfully to the IVD market. Working closely with the CTO and, you will manage relationships with external contractors, maintain the relevant design history documentation and ensure our product development activities comply with applicable quality systems and regulatory requirements.
- Work with the CTO to successfully deliver product development projects to required timescales
- Manage strategic relationships with suppliers, manufacturers and partners, including representing FluoretiQ at external meetings
- Ensure the appropriate regulatory records are kept throughout product development
- Use creative solutions to ensure product gets to the end user
- Prepare and maintain project specific Design History Files
- Work with the R&D team in design and execution of experimental work
- Keep accurate and complete records of all experimental work performed
- Write technical reports for both internal and external circulation
- Co-ordinate and drive project activities
- Prepare and review data and company documentation as required
- Support the commercial team with technical enquiries and support collaborative proposals
- Ensure that all work complies with quality audit processes
- Attend product meetings and prepare quarterly reports for submission to management
Who You Are
- You are a self-motivated team player with a science degree an applicable discipline (Microbiology, Biomedical Sciences) with strong analytical skills and experience developing assays for diagnostic applications
- You have 3-5 years’ experience in the in-vitro diagnostics sector.
- You have strong communication (written and verbal), interpersonal, relationship building, project management, and laboratory skills.
- You can demonstrate a proven ability to identify and pursue strategic opportunities, set and meet aggressive objectives, and drive key business priorities.
- You have experience with the IVDD/IVDR and relevant quality management environments (ISO 13485)
- You are aware of Intellectual Property Rights and management
Job Types: Full-time, Contract, Permanent
Salary: £35,000.00-£40,000.00 per year
- Company pension
- On-site parking
- Store discounts
- Work from home
- Monday to Friday
- Have you had prior experience developing an in vitro diagnostic product?
- Have you worked within an ISO 13485 compliant quality management system?
- Master’s (preferred)
- Remote interview process
- Social distancing guidelines in place
- Virtual meetings
- Sanitisation, disinfection or cleaning procedures in place