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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 enhancing healthcare through quality management and regulatory compliance.
- Benefits: Enjoy remote work flexibility, professional development opportunities, and a supportive team environment.
- Why this job: Make a real impact in healthcare while working with a dynamic team and gaining valuable experience.
- Qualifications: Must have a degree in relevant sciences and experience in medical device regulations and quality management.
- Other info: This role involves travel and offers opportunities for international collaboration and training.
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.
Medical Device Lead Auditor employer: Kenton Black Ltd
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 employers, and don’t hesitate to reach out on platforms like LinkedIn to connect with current auditors or those in regulatory affairs.
✨Tip Number 2
Stay updated on the latest regulations and standards in the medical device sector. Subscribe to industry newsletters or join professional groups to ensure you’re aware of any changes that could impact your role as an auditor.
✨Tip Number 3
Consider obtaining additional certifications, such as becoming a registered IRCA lead auditor. This can enhance your credibility and make you a more attractive candidate for the position.
✨Tip Number 4
Prepare for interviews by practising common questions related to auditing and compliance in the medical device field. Be ready to discuss specific experiences where you ensured compliance or improved processes, as this will demonstrate your expertise.
We think you need these skills to ace Medical Device Lead Auditor
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and qualifications required for the Medical Device Lead Auditor position. This will help you tailor your application to highlight relevant experience.
Tailor Your CV: Customise your CV to reflect your experience in the healthcare or medical device industry. Emphasise your knowledge of medical device regulations and any relevant certifications, 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.
Highlight Relevant Skills: In your application, be sure to highlight your technical skills, such as proficiency in MS Office and experience with large databases. Also, mention your ability to provide training and support, as this is crucial for the role.
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 suitability for the role.
✨Showcase Your Audit Experience
Prepare specific examples of your past auditing experiences, particularly in the healthcare or medical device industry. Highlight how you managed audits, ensured compliance, and contributed to customer satisfaction.
✨Demonstrate Project Management Skills
Be ready to discuss how you've successfully managed projects related to medical device procedures and documentation. Emphasise your ability to meet deadlines and stay within budget while maintaining high standards.
✨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, showcasing your ability to provide technical support and training.
