At a Glance
- Tasks: Ensure medical devices meet regulatory standards and maintain compliance throughout their lifecycle.
- Company: Exciting medical device organisation with a focus on innovation and quality.
- Benefits: Gain valuable experience in a regulated environment with opportunities for professional growth.
- Other info: Collaborate with diverse teams and contribute to continuous improvement in quality processes.
- Why this job: Make a real impact in healthcare by ensuring product safety and compliance.
- Qualifications: Experience in medical devices or regulated environments, strong technical writing skills.
The predicted salary is between 47250 - 57750 £ per year.
We are looking for an experienced Compliance Engineer to join an exciting medical device organisation and support regulatory compliance across the full product lifecycle. This medical device Compliance Engineer opportunity would suit someone with strong technical documentation experience who enjoys working across Quality, Engineering, NPD and Manufacturing within a highly regulated environment.
The Role
As Compliance Engineer, you will be responsible for creating, reviewing and maintaining regulatory and technical documentation to ensure products remain compliant and audit-ready. Key Compliance Engineer responsibilities will include:
- Authoring and maintaining Technical Files, Design Dossiers and regulatory documentation.
- Supporting EU MDR and UK regulatory compliance activities.
- Preparing technical reports, declarations and compliance records.
- Supporting regulatory submissions, registrations and market access activities.
- Reviewing documentation for accuracy, completeness and regulatory compliance.
- Managing documentation updates following design, process or regulatory changes.
- Supporting risk management and design control documentation.
- Assisting with Notified Body, Competent Authority and external audit requirements.
- Monitoring changes to regulations, standards and guidance.
- Supporting post-market compliance and regulatory change assessments.
- Contributing to continuous improvement of Quality and Regulatory processes.
About You
The successful Compliance Engineer will ideally have:
- Experience within medical devices (ISO13485), pharmaceuticals or another regulated life sciences environment.
- Strong experience creating and maintaining controlled technical documentation.
- Knowledge of EU MDR 2017/745, ISO 13485 and ISO14971.
- Understanding of design control, risk management and technical documentation requirements.
- Experience supporting regulatory submissions or Technical File activities.
- Excellent technical writing and attention to detail.
- Strong organisational and cross-functional communication skills.
The Compliance Engineer will work closely with Quality, Engineering, Product Development and Manufacturing teams, providing compliance input into both existing products and new product development. This Compliance Engineer position offers the opportunity to take ownership of meaningful compliance activities while developing broader exposure across regulatory submissions, product lifecycle management and international medical device requirements. If you are a medical device Compliance Engineer looking for a technically varied role within a regulated medical device environment, apply to discuss the opportunity in more detail.
Compliance Engineer in Doncaster employer: Aurora Life Sciences
As a Production Manager in our dynamic and innovative medical device manufacturing environment, you'll thrive in a culture that prioritises employee development and operational excellence. We offer comprehensive training programs, a collaborative work atmosphere, and the chance to lead impactful Lean and Six Sigma initiatives that drive continuous improvement. Join us to make a meaningful difference while enjoying a supportive workplace that values safety, quality, and your professional growth.
StudySmarter Expert Advice🤫
We think this is how you could land Compliance Engineer in Doncaster
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Aurora Life Sciences looking for candidates who are engaged and informed.
We think you need these skills to ace Compliance Engineer in Doncaster
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Aurora Life Sciences. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Aurora Life Sciences
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Aurora Life Sciences’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
