Production Compliance Engineer

Oxford Nanopore Technologies Ltd.; Oxford; Hybrid; GBP 50,000 - 70,000; Full time

Benefits offered by this job

Bonus

Generous pension contributions

Private healthcare

Job summary

Oxford Nanopore Technologies Ltd. is seeking a Production Compliance Engineer to support regulatory filings and keep the product catalogue compliant.

You will work with engineering and third party consultants to manage technical files, market access activities and design change assessments. The role requires a degree in mechanical engineering or similar in a highly regulated field, with hands-on experience in producing regulatory documentation and risk assessments.

Qualifications

• Degree in mechanical engineering (or similar) with regulated industry background.
• Experience in regulatory/compliance roles and producing product technical files.
• Experience with risk assessments and regulatory change management.

Responsibilities

• Lead design change assessment projects within regulatory context.
• Produce and maintain regulatory documentation for products.
• Provide technical and regulatory input to design and development.
• Manage global market access activities for new and existing products.
• Monitor changes in regulations and standards; coordinate third party testing.

Skills

Regulatory compliance

Technical documentation

Risk assessment

Cross-functional communication

Education

Mechanical Engineering Degree

Tools

Microsoft Project

Excel

Visio

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 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.
• Provide technical and regulatory requirements to the design and development process.
• Managing global market access activities for new and existing products.
• Monitor and manage changes in regulations, directives and standards.
• Lease and organise third party testing and consultants.
• Knowledge sharing, and support of market and regulatory requirements.

What We're Looking For...

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. Alongside a technical background, you’ll be a strong communicator, with excellent writing skills enabling you to share knowledge of the field. You'll also be proficient in Microsoft Applications including Project Excel and Visio.

This role will suit someone who enjoys working collaboratively with others from multi-disciplinary teams. This is an excellent opportunity to work in a cutting-edge, high-tech industry in a fast-paced working environment on exciting projects where you can make an impact.

We offer outstanding benefits to include an attractive bonus, generous pension contributions, private healthcare and an excellent starting salary.

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.