Medical Device Electronics Regulatory Engineer

Overview

Senior Systems & Regulatory Software Engineer

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

We are seeking an experienced Technical Expert with experience working for a certification or regulatory body. Experience working with active medical devices under MDR 2017/745 and ISO 13485 standards 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.

You must be able to evidence the regulatory body you have worked with and also the familarity and experience with the MDA codes listed below.

• 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

• 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
• Willingness to travel occasionally for national or international audits

• 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