Job Description
Oxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere.
The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis.
The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins.
The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments.
With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.
We are looking for a highly motivated individual to join our engineering team as a Production Compliance Engineer to Engineer to support compliance activities of new product releases and managing current product catalogue. This is an exciting opportunity for someone passionate about new technology.
The Details...
Reporting to the Associate Director of Production Engineering, you'll work with executive management and third party consultants to manage regulatory compliance files and documentation to ensure Nanopore products meet required standards. This will include, but not limited to, producing/ managing product technical files, global market access activities, design change assessments and supporting new product releases. You will be the first contact for Engineering on all areas relating to compliance. This is an opportunity to own the process and area, with the flexibility of introducing/ managing the compliance process.
Other Duties Include
- Lead representative for design change assessment projects.
- Produce, manage and maintaining regulatory documentation.