At a Glance
- Tasks: Conduct audits and assessments for medical devices, ensuring compliance with ISO13485 and MDR standards.
- Company: Join DNV, a leader in certification with a commitment to integrity and diversity.
- Benefits: Enjoy flexible work arrangements, generous paid leave, and comprehensive medical benefits.
- Why this job: Make a real impact in the medical device industry while advancing your career.
- Qualifications: Bachelor's degree in medical science or related field; 4 years of relevant experience required.
- Other info: Be part of a diverse team that values continuous learning and development.
The predicted salary is between 36000 - 60000 £ per year.
Conduct audits and assessments in accordance with ISO13485, MDSAP, MDR based on the directive, regulation, harmonized standards and other applicable regulatory requirements following DNV’s accredited certification program and procedure.
Ensure independence and ethics of all auditing activities, upholding DNV’s values of integrity and impartiality.
Contribute to continuous improvement efforts by identifying and driving enhancements in audit processes, information management, and service delivery across teams.
Plan and deliver client projects such as assessments, gap analyses, training workshops, and other consultancy activities as assigned.
Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities.
Perform additional duties as assigned by the line manager to support team and business objectives.
Flexible work arrangements for better work-life balance.
Generous Paid Leaves (Annual Paid Leave, Sick Leave).
Medical benefits (Standard medical check-up).
Pension and Insurance Policies.
Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme).
Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Professional Membership Fees).
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.
Relevant Bachelor or higher degree related to medical science and medical device area. Core disciplines: biology or microbiology; biomechanical engineering; chemistry or biochemistry; medicine and clinical practice; computer and software technology; electrical, electronic, mechanical or bioengineering.
Minimum 4 years of hands-on experience in the design, manufacturing, testing, or clinical use of medical devices within industry, laboratory, or hospital environments. Preferred product group: MDN1206 non-active ophthalmologic device, MDN1201 non-active device for anaesthesia, emergency and intensive care, MDN1202 non-active device for administration, channelling and removal of substances, including dialysis.
High customer focus and service orientation.
Strong communication and interpersonal skills.
Proven ability to work collaboratively in teams and across functions.
Self-motivated with strong commitment to continuous learning and development.
Fluency in both written and spoken English is required.
Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.
ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung in London employer: DNV Germany Holding GmbH
Contact Detail:
DNV Germany Holding GmbH Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry, especially those who work with ISO13485 and MDR. Attend relevant events or webinars to make connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of auditing processes and regulations. Be ready to discuss how you can contribute to continuous improvement efforts at DNV, showcasing your experience in the field.
✨Tip Number 3
Don’t just apply anywhere; focus on our website! We often have exclusive job postings that might not be listed elsewhere. Plus, it shows you're genuinely interested in joining our team.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. It’s a great chance to reiterate why you’re the perfect fit for the ISO13485 & MDR Auditor position.
We think you need these skills to ace ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience with ISO13485, MDSAP, and MDR. We want to see how your background aligns with the specific requirements of the role, so don’t be shy about showcasing relevant projects or achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about auditing and how your skills can contribute to our team. We love seeing enthusiasm and a personal touch, so let your personality come through.
Showcase Your Continuous Learning: Since we value continuous improvement, mention any recent training or certifications you've completed. This shows us that you're committed to staying updated in the field and ready to bring fresh ideas to the table.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at DNV Germany Holding GmbH
✨Know Your Standards
Make sure you’re well-versed in ISO13485, MDSAP, and MDR regulations. Brush up on the latest updates and how they apply to auditing processes. This will show your potential employer that you’re not just familiar with the standards but also committed to staying current.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve conducted audits or assessments. Highlight your hands-on experience with medical devices and how you’ve contributed to continuous improvement efforts. This will help demonstrate your practical knowledge and problem-solving skills.
✨Emphasise Team Collaboration
Since the role involves working across teams, be ready to discuss how you’ve successfully collaborated with others in previous positions. Share instances where your strong communication and interpersonal skills made a difference in achieving project goals.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s audit processes and how they ensure compliance with regulatory requirements. 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.
