Medical Device Electronics Regulatory Engineer

Senior Systems & Regulatory Software Engineer

Medical Devices | High Salary or High-Rate Contract | Kent | Remote

We are seeking an experienced Technical Expert to join our global team, working with active medical devices under MDR 2017/745 and ISO 13485 standards Electrionics device and audit experience is recognised.

This is a fully remote role, offering the flexibility to work from anywhere, while engaging with international clients and supporting the certification of a diverse portfolio of medical device manufacturers.

What You’ll Be Doing

• Reviewing technical documentation for active medical devices and assessing compliance with EU MDR 2017/745
• Evaluating Quality Management Systems (QMS) in line with ISO 13485
• Managing certification activities for an international portfolio of medical device manufacturers
• Collaborating with teams and clients across multiple regions to ensure consistent, high-quality compliance

What We’re Looking For

• Bachelor’s or postgraduate degree in biomedical engineering, biotechnology, biology, chemistry, pharmacy, bioengineering, or equivalent
• Several years’ experience in the active medical device industry, ideally with a Notified Body
• Expertise with MDA codes 0202, 0203, 0204, 0302, 0303, 0305, 0306, 0307, 0308, 0312, 0313, 0315, 0316, 0317, 0318 for ECM
• Excellent English communication skills (minimum B1)
• Willingness to travel occasionally for national or international audits

Why This Role?

• Remote-first working with flexible hours
• Exposure to a varied international portfolio of medical device manufacturers
• Work at the cutting edge of medical device compliance
• Collaborate with industry-leading experts across multiple regions