Production Compliance Engineer — Global Regulatory Lead

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 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.