Medical Device Electronics Regulatory Engineer
hace 2 días
Liverpool
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