Commercial Gas Engineer

Gist Ltd.; Oxford; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading technology company seeks a Compliance Engineer in Oxford to ensure regulatory compliance and manage safety documentation. Collaborating with cross-functional teams, you'll be responsible for product safety standards for diverse projects. Ideal candidates will have experience with IEC safety regulations and strong communication skills. The role requires office attendance for at least 3 days a week, with occasional travel necessary. Join us to make a significant impact in the safety of our products.

Qualifications

• Experience with regulatory compliance testing.
• Strong understanding of safety standards such as IEC 60601-1 and IEC 62368-1.
• Ability to compile safety documentation for global clearances.

Responsibilities

• Compile key requirements and safety documentation for regulatory approvals.
• Ensure Vision RT products meet current regulatory standards.
• Manage third-party testing activities related to safety standards.
• Review and update the company QMS for compliance with regulations.
• Perform Design Safety Risk Management activities.

Skills

Regulatory understanding

Risk management

Team collaboration

Safety documentation

Testing methodologies

Communication skills

Job description

Working closely with different teams throughout Vision RT, the Compliance Engineer will be responsible for compiling key requirements and safety documentation required for global regulatory clearances and approvals. As part of the Hardware Team, this role will involve close collaboration with Regulatory, Quality Software Development, Production and Service teams, as well as third parties. Key safety documentation includes top-level Design History File documentation required to demonstrate regulatory compliance with standards relating to Safety for all the products in the Vision RT portfolio. This role will be located in our Basingstoke office, and occasional travel to other offices or for supporting 3rd party testing will be required.

• Assuring that Vision RT products meet current regulatory requirements, standards and guidance using 'State of the Art' methods and techniques for Safety.
• Establishing product requirements and associated testing approaches required to meet regulatory standards.
• Working closely with development teams and the regulatory team to ensure safety deliverables are met for product releases.
• Assisting in planning and managing third‑party testing activities for testing to (IEC 60601-1 and IEC 62368-1) General Safety and EN 60601-2 / EN 61000-4‑2 (EMC) and related standards.
• Reviewing and updating the company QMS in relation to Safety to ensure they comply with existing and emergent regulatory requirements and guidance.
• Performing Design Safety Risk Management activities.
• Training and mentoring others to understand current regulatory requirements, standards and guidance.
• Must be willing and able to travel nationally (occasionally) or internationally (infrequently) as necessary.
• Must be able to work at least 3 days a week from the office.