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