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 characterize 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.
Responsibilities
Reporting to the Associate Director of Production Engineering, you will work with executive management and third‑party consultants to manage regulatory compliance files and documentation to ensure Nanopore products meet required standards. This includes, but is not limited to, producing and 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, and you will own the process and introduce or manage the compliance process.
- Lead representative for design change assessment projects.
- Produce, manage, and maintain regulatory documentation.
- Provide technical and regulatory requirements to the design and development process.
- Manage global market access activities for new and existing products.
- Monitor and manage changes in regulations, directives, and standards.
- Lease and organize third‑party testing and consultants.
- Knowledge sharing, and support of market and regulatory requirements.
Qualifications
We’ll expect you to have a degree in mechanical engineering or a similar subject, with a background working in a highly regulated industry such as medical or aerospace. Relevant working experience in a regulatory or compliance‑based role is a must, with tangible experience in producing/maintaining product technical files, risk assessments and GMA. You should have strong communication skills, excellent writing abilities for knowledge sharing, and proficiency in Microsoft applications including Project, Excel, and Visio.
This role is ideal for someone who enjoys working collaboratively with multidisciplinary teams and seeks to influence cutting‑edge, high‑tech projects in a fast‑paced environment.
Benefits
We offer outstanding benefits including an attractive bonus, generous pension contributions, private healthcare, and an excellent starting salary.
Equal Opportunity Statement
Please note that no terminology in this advert is intended to discriminate on the grounds of a person’s gender, marital status, race, religion, colour, age, disability, or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications, and abilities to perform the duties of the job.
#J-18808-Ljbffr…