RemotevilleRemote Quality and Regulatory Manager Job in UK GenomeKey
Quality and Regulatory Manager GenomeKey
£55000 - £65000
Data EngineeringSoftware DevelopmentData ScienceMachine LearningMachine Learning AlgorithmsPattern Recognition
Senior (5-8 years) -
UK
GenomeKey enables targeted Sepsis treatment in hours, rather than days
20+ employees
BiotechnologyHealthcareArtificial IntelligenceMedical Device
Role
Who you are
- Degree in Life Sciences, Biology, Engineering, or a related field required.
- Minimum of 5 years of experience in a similar role within the biotech or medical device industry.
- Strong technical acumen across software and biological/hardware products.
- In-depth knowledge of relevant regulations like ISO 13485, ISO 14971, and ISO/IEC 62304.
- Excellent project management, collaboration, and communication skills.
Desirables
- Machine Learning knowledge
- Sequencing tech experience
What the job involves
- Ensure the highest standards of quality and regulatory compliance.
- Implement and maintain a robust Quality Management System (QMS).
- Lead the development of Technical Files for UKCA marking.
- Manage regulatory submissions for various products and regions.
- Collaborate on incorporating compliance in product design and development.
Company
Company mission
GenomeKey is dedicated to revolutionizing sepsis treatment by developing a next-generation diagnostic device that significantly reduces the time to identify effective antibiotics from days to mere hours. By leveraging advanced machine learning and DNA sequencing technologies, we aim to enhance patient outcomes while conserving vital antibiotics for critical cases, ultimately saving lives and healthcare costs.Company benefits
- Pension contributions
- Flexible working around core hours
- Remote working possibilities
- Commitment to personal development
Company values
- Innovation
- Collaboration
- Quality
- Integrity
- Impact