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- Tasks: Plan and conduct audits for medical device management systems, ensuring compliance and customer satisfaction.
- Company: Join a leading firm in the healthcare sector focused on quality and regulatory standards.
- Benefits: Enjoy remote work flexibility and opportunities for international travel.
- Why this job: Make an impact in healthcare while developing your skills in a dynamic and supportive environment.
- Qualifications: Experience in healthcare or medical devices, with a relevant degree and knowledge of regulations required.
- Other info: Ideal for those passionate about quality management and looking to grow in a vital industry.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Job Title: Medical Device Auditor\\nLocation: Remote , UK Based\\nTravel: Will be required \\n\\nOur client is looking for a Medical Device Auditor to plan and conduct professional management system audits in accordance to the company’s procedures. \\nKey Responsibilities:\\n•\\tConduct audits at client sites or remotely to meet regulatory and stakeholder requirements.\\n•\\tComplete all chargeable work within budget and timelines to ensure customer satisfaction.\\n•\\tManage specific projects related to medical device procedures, systems, and documentation.\\n•\\tProvide accurate and timely reporting for planning and operational management.\\n•\\tOversee auditing teams to enhance client satisfaction and ensure compliance.\\n•\\tManage personal schedule to meet chargeability targets.\\n•\\tProvide technical support and training to staff both in the UK and internationally.\\n•\\tSupport business development efforts, including sales visits and event participation.\\n•\\tConduct internal audits to ensure compliance with standards.\\n•\\tMaintain and update personal training records and certifications.\\nQualifications & Experience:\\nEssential:\\n•\\tProven experience in the healthcare or medical device industry, with experience in quality management.\\n•\\tStrong knowledge of medical device regulations: EU MDD 93/42/EEC, MDR 2017/745, IVDR 2017/746, UK MDR 2002, ISO 13485, MDSAP.\\n•\\tExperience in regulatory affairs, quality management, or clinical evaluations.\\n•\\tCompetent in using MS Office and large databases.\\n•\\tFull UK driving license.\\n•\\tUniversity degree or equivalent in relevant sciences (e.g., Medicine, Pharmacy, Biochemistry, Biomedical Engineering).\\nDesirable:\\n•\\tRegistered IRCA lead auditor or similar certification.\\n•\\tExperience in reviewing technical documentation and audit packs
Medical Device Lead Auditor employer: Kenton Black
Contact Detail:
Kenton Black Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Device Lead Auditor
✨Tip Number 1
Make sure to familiarize yourself with the specific medical device regulations mentioned in the job description, such as EU MDD and ISO 13485. This knowledge will not only help you during the interview but also demonstrate your commitment to the role.
✨Tip Number 2
Highlight any previous experience you have in conducting audits or managing projects related to medical devices. Be prepared to discuss specific examples that showcase your ability to meet regulatory requirements and enhance client satisfaction.
✨Tip Number 3
Since this role involves remote work and travel, emphasize your flexibility and ability to manage your schedule effectively. Share any experiences where you successfully balanced multiple projects or deadlines.
✨Tip Number 4
If you have any certifications, like being a registered IRCA lead auditor, make sure to mention them. These credentials can set you apart from other candidates and show your dedication to professional development.
We think you need these skills to ace Medical Device Lead Auditor
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Medical Device Lead Auditor position. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in the healthcare or medical device industry, particularly in quality management and regulatory affairs. Use specific examples to demonstrate your expertise with relevant regulations like ISO 13485 and EU MDR.
Showcase Your Skills: Mention your proficiency in using MS Office and large databases, as well as any certifications such as being a registered IRCA lead auditor. This will strengthen your application and show that you meet the essential qualifications.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also expresses your enthusiasm for the role. Discuss how your skills align with the company's goals and how you can contribute to their success.
How to prepare for a job interview at Kenton Black
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of medical device regulations such as EU MDD, MDR, and ISO 13485 during the interview. Be prepared to discuss how you've applied this knowledge in previous roles.
✨Demonstrate Audit Experience
Share specific examples of audits you have conducted, focusing on your role in managing teams and ensuring compliance. This will help illustrate your hands-on experience and leadership skills.
✨Prepare for Technical Questions
Expect questions related to quality management systems and regulatory affairs. Brush up on your technical knowledge and be ready to explain complex concepts clearly and concisely.
✨Discuss Project Management Skills
Since the role involves managing specific projects, be ready to talk about your project management experience. Highlight how you have successfully met deadlines and managed budgets in past projects.
