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For Companies At a Glance
- Tasks: Review and assess compliance of medical devices with EU regulations.
- Company: Global leader in medical device compliance with a remote-first culture.
- Benefits: High salary, flexible hours, and the chance to work from anywhere.
- Why this job: Join a dynamic team and make a real impact in healthcare innovation.
- Qualifications: Degree in biomedical engineering or related field; experience in medical devices.
- Other info: Collaborate with international clients and experts in a cutting-edge environment.
The predicted salary is between 36000 - 60000 £ per year.
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. Electronics 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
Medical Device Electronics Regulatory Engineer in Kingston upon Hull employer: X4 Technology
Contact Detail:
X4 Technology Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Device Electronics Regulatory Engineer in Kingston upon Hull
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR 2017/745 and ISO 13485 standards. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your experience with active medical devices during interviews. We suggest using specific examples from your past roles to demonstrate your skills and how they align with the job requirements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Medical Device Electronics Regulatory Engineer in Kingston upon Hull
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in the active medical device industry and showcases your knowledge of MDR 2017/745 and ISO 13485. We want to see how your background aligns with what we're looking for, so don’t be shy about emphasising relevant skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about medical devices and how your expertise can contribute to our team. We love seeing genuine enthusiasm, so let your personality come through!
Showcase Your Communication Skills: Since excellent English communication skills are a must, make sure your application is clear and well-structured. We appreciate attention to detail, so double-check for any typos or grammatical errors before hitting send!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It helps us keep track of applications better and ensures you’re considered for the role without any hiccups. Plus, it’s super easy!
How to prepare for a job interview at X4 Technology
✨Know Your Regulations
Make sure you brush up on the EU MDR 2017/745 and ISO 13485 standards before your interview. Being able to discuss these regulations confidently will show that you’re not just familiar with them, but that you understand their implications in the medical device industry.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience with active medical devices and compliance assessments. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easier for the interviewer to see your impact.
✨Communicate Clearly
Since excellent English communication skills are a must, practice articulating your thoughts clearly and concisely. You might even want to do a mock interview with a friend or colleague to get comfortable discussing technical topics in an easy-to-understand way.
✨Be Ready to Collaborate
This role involves working with international teams, so be prepared to discuss how you’ve successfully collaborated across different regions in the past. Highlight any experiences where you’ve navigated cultural differences or worked remotely to achieve a common goal.
