Regulatory & Safety Engineer - Medical Devices

Vision RT Ltd; Basingstoke; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading MedTech company in the UK is seeking a Compliance Engineer to compile key requirements and safety documentation for regulatory clearances. The ideal candidate will have a degree in a science or engineering-based subject and over 3 years of experience in regulatory compliance for medical devices. Responsibilities include assuring product compliance, managing testing activities, and updating quality management systems. The role offers full-time employment and requires occasional travel. Exceptional attention to detail and teamwork skills are essential.

Qualifications

• More than 3 years’ experience in regulatory compliance for medical devices.
• Experience in risk management and quality management is preferable.

Responsibilities

• Assuring products meet current regulatory requirements and standards.
• Establishing product requirements and associated testing approaches.
• Collaborating with teams to ensure safety deliverables for product releases.
• Managing third-party testing activities according to safety standards.
• Updating the QMS to comply with regulatory requirements.
• Conducting Design Safety Risk Management activities.

Skills

Product requirements relating to safety standards (i.e. ISO, IEC, etc)

Testing methods

Excellent attention to detail

Excellent prioritising, organisational, and interpersonal skills

Fluent in English

Computer Proficiency with MS Office

Strong organisational skills

Ability to work in a fast-paced environment

Critical thinking and problem-solving skills

Detail-oriented and adaptable attitude

Education

Degree in science or engineering-based subject

Job description

A leading MedTech company in the UK is seeking a Compliance Engineer to compile key requirements and safety documentation for regulatory clearances. The ideal candidate will have a degree in a science or engineering-based subject and over 3 years of experience in regulatory compliance for medical devices. Responsibilities include assuring product compliance, managing testing activities, and updating quality management systems. The role offers full-time employment and requires occasional travel. Exceptional attention to detail and teamwork skills are essential.