At a Glance
- Tasks: Review and assess compliance of active medical devices with EU regulations.
- Company: Leading consultancy in medical device certification with a global reach.
- Benefits: High salary, remote work flexibility, and opportunities for international collaboration.
- Other info: Work remotely with flexible hours and engage with diverse international clients.
- Why this job: Join a dynamic team and make a real impact on healthcare innovation.
- Qualifications: Degree in biomedical engineering or related field; experience in medical device compliance.
The predicted salary is between 48000 - 72000 £ per year.
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 familiarity 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
Requirements:
- 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
- Excellent English communication skills (minimum B1)
- 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.
Electronics Engineer Consultant - Medical Devices employer: X4 Technology
Contact Detail:
X4 Technology Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Electronics Engineer Consultant - Medical Devices
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Show off your expertise! When you get the chance to chat with potential employers, be ready to discuss your experience with MDR 2017/745 and ISO 13485. Highlight specific projects where you've made an impact to really stand out.
✨Tip Number 3
Don’t shy away from remote interviews! Prepare your tech setup and ensure you’re comfortable with video calls. Practice answering common interview questions and be ready to discuss how you can manage certification activities effectively.
✨Tip Number 4
Apply through our website! We’ve got loads of exciting roles that match your skills. Plus, applying directly gives you a better chance of being noticed by our hiring team. Let’s get you that dream job!
We think you need these skills to ace Electronics Engineer Consultant - Medical Devices
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Electronics Engineer Consultant. Highlight your experience with active medical devices and any relevant certifications or regulatory bodies you've worked with. We want to see how your background aligns with the job description!
Showcase Your Experience: In your application, be specific about your experience with EU MDR 2017/745 and ISO 13485 standards. We love details! Share examples of how you've managed certification activities or evaluated Quality Management Systems in the past.
Keep It Professional Yet Engaging: While we appreciate a friendly tone, remember to keep your application professional. Use clear language and avoid jargon that might confuse us. We want to understand your qualifications without getting lost in technical terms!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy and straightforward!
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. Be ready to discuss how your previous experience aligns with these regulations, as this will show your expertise and familiarity with the requirements.
✨Showcase Your Technical Skills
Prepare to talk about specific projects where you've reviewed technical documentation for active medical devices. Highlight any compliance assessments you've conducted and how they contributed to successful certification activities.
✨Demonstrate Communication Skills
Since this role involves collaborating with international clients, practice articulating your thoughts clearly in English. You might even want to prepare a few examples of how you've effectively communicated complex regulatory information to diverse teams.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think of situations where you had to manage certification activities or evaluate Quality Management Systems, and be prepared to explain your approach and outcomes.