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- Tasks: Conduct audits and manage projects in the medical device sector, ensuring compliance and client satisfaction.
- Company: Join a leading firm dedicated to quality in healthcare and medical devices.
- Benefits: Enjoy remote work flexibility, travel opportunities, and professional development support.
- Why this job: Make a real impact in healthcare while working with a dynamic team and enhancing your skills.
- Qualifications: Experience in medical devices and quality management is essential; a relevant degree is required.
- Other info: Opportunity for international training and involvement in business development activities.
The predicted salary is between 36000 - 60000 £ per year.
Location: Remote, UK Based
Travel: Will be required
Our client is looking for a Medical Device Auditor to plan and conduct professional management system audits in accordance with the company’s procedures.
Key Responsibilities:
- Conduct audits at client sites or remotely to meet regulatory and stakeholder requirements.
- Complete all chargeable work within budget and timelines to ensure customer satisfaction.
- Manage specific projects related to medical device procedures, systems, and documentation.
- Provide accurate and timely reporting for planning and operational management.
- Oversee auditing teams to enhance client satisfaction and ensure compliance.
- Manage personal schedule to meet chargeability targets.
- Provide technical support and training to staff both in the UK and internationally.
- Support business development efforts, including sales visits and event participation.
- Conduct internal audits to ensure compliance with standards.
- Maintain and update personal training records and certifications.
Qualifications & Experience:
Essential:
- Proven experience in the healthcare or medical device industry, with experience in quality management.
- Strong knowledge of medical device regulations: EU MDD 93/42/EEC, MDR 2017/745, IVDR 2017/746, UK MDR 2002, ISO 13485, MDSAP.
- Experience in regulatory affairs, quality management, or clinical evaluations.
- Competent in using MS Office and large databases.
- Full UK driving license.
- University degree or equivalent in relevant sciences (e.g., Medicine, Pharmacy, Biochemistry, Biomedical Engineering).
Desirable:
- Registered IRCA lead auditor or similar certification.
- Experience in reviewing technical documentation and audit packs.
Contact Detail:
Kenton Black Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Device Lead Auditor
✨Tip Number 1
Network with professionals in the medical device industry. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends and regulations. This can help you gain insights into what companies like us are looking for in a candidate.
✨Tip Number 2
Familiarise yourself with the specific regulations mentioned in the job description, such as EU MDD and ISO 13485. Being able to discuss these regulations confidently during an interview will demonstrate your expertise and commitment to the role.
✨Tip Number 3
Prepare to showcase your auditing experience by thinking of specific examples where you've successfully managed audits or projects. Highlighting your ability to meet deadlines and ensure compliance will make you stand out to us.
✨Tip Number 4
Stay updated on the latest developments in medical device regulations and quality management. Subscribing to industry newsletters or joining professional groups can provide valuable information that you can bring up in discussions with us.
We think you need these skills to ace Medical Device Lead Auditor
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Medical Device Lead Auditor. Familiarise yourself with the key requirements and expectations outlined in the job description.
Tailor Your CV: Highlight your relevant experience in the healthcare or medical device industry. Emphasise your knowledge of medical device regulations and any certifications you hold, such as being a registered IRCA lead auditor.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality management and regulatory affairs. Mention specific experiences that demonstrate your ability to conduct audits and manage projects effectively.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that all information is clear, concise, and relevant to the position to make a strong impression.
How to prepare for a job interview at Kenton Black Ltd
✨Know Your Regulations
Familiarise yourself with the key medical device regulations mentioned in the job description, such as EU MDD, MDR, and ISO 13485. Being able to discuss these regulations confidently will demonstrate your expertise and understanding of the industry.
✨Showcase Your Audit Experience
Prepare specific examples from your past experience where you successfully conducted audits or managed auditing teams. Highlight how you ensured compliance and client satisfaction, as this is crucial for the role.
✨Demonstrate Project Management Skills
Be ready to discuss how you manage projects related to medical device procedures and documentation. Share any tools or methodologies you use to stay organised and meet deadlines, as this will show your ability to handle the responsibilities of the position.
✨Prepare for Technical Questions
Expect technical questions related to quality management and regulatory affairs. Brush up on your knowledge and be prepared to explain complex concepts clearly, as this will reflect your capability to provide technical support and training.
