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- Tasks: Lead audits and review technical documentation for medical devices to ensure compliance.
- Company: Join a global leader in medical device certification and quality assurance.
- Benefits: Competitive salary, professional development, and a commitment to diversity.
- Why this job: Make a real impact on healthcare by ensuring the safety and quality of medical technologies.
- Qualifications: 5+ years as Lead Auditor with experience in medical device manufacturing.
- Other info: Dynamic work environment with opportunities for growth and learning.
The predicted salary is between 36000 - 60000 £ per year.
About Life Sciences We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long-term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers—driving sustainable results and improved ESG performance.
DNV Product Assurance AS is a designated Notified Body for Medical Device Regulation and In-Vitro Diagnostic Regulation, Accredited Certification Body for ISO 13485 and Recognized Auditing Organization under MDSAP. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organization that invests in its employees, and is committed to providing you with continued development.
We are seeking a highly skilled and knowledgeable Medical Device Regulatory Lead Auditors and technical reviewers (final reviewers) to join our team. The successful candidate will be responsible for performing assessments of technical documentation for both IVDR and MDR non-active medical devices in accordance with the In-Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) and the processes defined by the DNV Quality Management System. This role involves also thorough review of audit reports to ensure accuracy and compliance, as well as effective communication with customers and internal Lead Auditors on various technical issues and requirements.
Key Responsibilities- Ensure compliance with IVDR and MDR, MDSAP, ISO 13485 and DNV Quality Management System process requirements
- Review audit reports for accuracy and adherence to regulatory standards
- Communicate effectively with customers and DNV Market unit Lead Auditors regarding requirements, status updates, and technical issues
- Provide detailed and accurate reporting of audit findings
- Perform audits of legal manufacturers (approx. 10 % of the working hours on performing audits)
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.
Qualifications- Work Experience:
- Minimum 5 years as Lead Auditor IVDR/MDR/MDSAP/ISO from a Notified Body
- Minimum 4 years of work experience in the medical device manufacturing sector
- At least two years of experience must be within quality management
- Approved as LA for sterility codes
- Strong written and verbal English communication skills
- Structured
- Analytical
- Excellent customer service skills
- Proficient in reporting and documentation
Lead Auditor/Technical Reviewer IVDR/MDR employer: DNV Germany Holding GmbH
Contact Detail:
DNV Germany Holding GmbH Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Auditor/Technical Reviewer IVDR/MDR
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend relevant events. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its values. We want you to show how your skills align with their mission in medical devices and healthcare. Tailor your responses to highlight your experience with IVDR and MDR.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors. We recommend focusing on common questions related to auditing and compliance to boost your confidence.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can leave a lasting impression. We believe it shows your enthusiasm and professionalism, which is key in the competitive field of medical device regulation.
We think you need these skills to ace Lead Auditor/Technical Reviewer IVDR/MDR
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Lead Auditor role. Highlight your experience with IVDR, MDR, and ISO 13485, as well as any relevant auditing experience. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about medical device regulation and how your background makes you a perfect fit for our team. Keep it concise but impactful!
Showcase Your Communication Skills: Since effective communication is key in this role, make sure your application reflects your strong written skills. Use clear and professional language, and don’t forget to proofread for any typos or errors!
Apply Through Our Website: We encourage you to apply directly 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 to do!
How to prepare for a job interview at DNV Germany Holding GmbH
✨Know Your Regulations
Make sure you brush up on the IVDR and MDR regulations before your interview. Being able to discuss these in detail will show that you’re not just familiar with the standards, but that you can apply them practically in your role as a Lead Auditor.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience in auditing and compliance. Discussing your hands-on experience with ISO 13485 and MDSAP will demonstrate your capability and confidence in handling the responsibilities of the role.
✨Communicate Clearly
Since effective communication is key in this role, practice articulating complex technical issues in a clear and concise manner. This will help you convey your thoughts effectively during the interview and show that you can communicate well with both customers and internal teams.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to quality management and how they ensure compliance with regulations. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your values and career goals.
