Lead Auditor & Technical Reviewer, Non-Active and Active Medical Devices

Job title:

Lead Auditor & Technical Reviewer, Non-Active and Active Medical Devices

Company

DNV

Job description

Job Description:DNV Product Assurance AS is a designated Notified Body for Medical Device Regulation and in process to be designated Notified Body for 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.Are you passionate about ensuring the safety and compliance of medical devices? Do you have a sharp eye for detail and deep expertise in regulatory standards? If so, we want YOU on our team!At DNV, we’re looking for experienced and highly skilled Medical Device Lead Auditors and Technical Reviewers (Final Reviewers) to help shape the future of medical device compliance. In this role, you’ll play a crucial part in assessing audit documentation for both active and non-active medical devices, ensuring they meet the highest industry standards.This is more than just a job-it’s a chance to make a real impact by working with cutting-edge medical technologies and collaborating with industry leaders.What You’ll Do:

• Conduct audits of legal manufacturers of medical devices (~10% of your time).
• Ensure compliance with MDR, MDSAP, ISO 13485, and DNV’s Quality Management System.
• Review audit reports with precision to guarantee accuracy and regulatory adherence.
• Serve as a key contact, providing necessary information to customers and internal Lead Auditors.
• Deliver clear, accurate reports on audit findings.

Responsibilities:

• A strong company culture with an emphasis on competence development
• Opportunity to collaborate with world-class universities and industry partners, publish work in international journals and attend scientific conferences.
• Great colleagues who value teamwork and support
• Attractive total compensation package
• 6 weeks annual vacation
• International working environment
• Flexible working hours and focus on work/life balance
• Interesting and challenging projects, both national and international
• Be part of a world-leading company that has a global reach with more than 15 000 employees around to world and is headquartered in Norway
• Close access to the sea and surrounding park with the possibility for different outdoor activities
• Free shuttle bus from Sandvika and Skøyen

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:What We’re Looking For:

• Education: MSc or PhD in a relevant field such as:

Biology, Microbiology, Biomechanical Engineering, Dentistry, Material/Biomaterial Science, Chemistry, Physics/Biophysics, Medical Technology, Pharmacy, Electrical, Electronics, Mechanical, or Bioengineering, Software Technology/AI, and more.Experience:

• 3+ years as an MDR Lead Auditor in a Notified Body.
• 4+ years in the medical device manufacturing sector, and at least 2+ years in quality management.

Skills:

• Strong written & verbal communication in English.
• Exceptional attention to detail.
• Excellent customer service & stakeholder management.
• Proficiency in documentation & reporting.

If you’re ready to take the next step in your career and contribute to the future of medical device compliance, we’d love to hear from you!Application deadline: 15th of April, 2025.

Expected salary

Location

Norge

Job date

Wed, 26 Mar 2025 08:22:05 GMT

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