Compliance Engineer - Medical Devices & ISO 13485

JASA Talent; Cheltenham; On-site; GBP 45,000 - 50,000; Full time

Job summary

A leading medical devices company in Cheltenham is seeking a Compliance Engineer. This role focuses on ensuring compliance with UK and EU standards, requiring experience in regulatory affairs and ISO 9001/13485. The ideal candidate should have hands-on experience with product testing, documentation, and continuous improvement processes. Competitive salary range of £45,000 to £50,000 is offered for the right candidate.

Qualifications

• Experience in compliance and regulatory affairs within the electronics or medical devices sector.
• Familiarity with ISO 13485 and 9001.
• Hands-on experience with product testing and validation.

Responsibilities

• Plan and oversee compliance and testing for medical products.
• Operate and maintain testing equipment.
• Ensure product compliance with relevant standards.
• Write and validate reports and documentation.
• Analyze test data.
• Drive continuous improvement initiatives.

Skills

Compliance and regulatory affairs experience

Electronics or medical devices experience

ISO 13485 and 9001 experience

Hands-on product test and validation experience

Testing and complying to IEC60601

Certification and documentation experience

Job description

A leading medical devices company in Cheltenham is seeking a Compliance Engineer. This role focuses on ensuring compliance with UK and EU standards, requiring experience in regulatory affairs and ISO 9001/13485. The ideal candidate should have hands-on experience with product testing, documentation, and continuous improvement processes. Competitive salary range of £45,000 to £50,000 is offered for the right candidate.