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 an experienced professional in medical devices looking to make a real impact? At DNV, we are seeking a highly skilled Medical Device Assessor and Technical Reviewer to join our team of experts. In this role, you will be at the forefront of ensuring medical devices meet the highest regulatory and safety standards.
As part of our team, you will conduct in-depth assessments of technical documentation for both active and non-active medical devices, ensuring full compliance with MDR and internal quality standards. You will also play a key role in reviewing assessment reports and collaborating with internal assessors and customers to address technical challenges.
What You’ll Be Doing:
- Conduct detailed assessments of technical documentation from medical device manufacturers.
- Ensure compliance with Medical Device Regulation (MDR) and DNV’s Quality Management System.
- Review assessment reports and related technical documentation with precision and attention to detail.
- Communicate effectively with customers and internal assessors to clarify requirements and address technical issues.
- Deliver accurate, well-documented reports on assessment findings.
- 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
What We’re Looking For:
- 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:
- Minimum 4 years of experience in the medical device manufacturing sector.
- At least 2 years in design, scientific aspects, manufacturing, testing, or the use of medical devices.
Skills:
- Strong written and verbal communication in English.
- Excellent attention to detail and analytical skills.
- Ability to provide top-tier customer service and manage stakeholder relationships.
- Proficiency in documentation and regulatory reporting.
If you are ready to take your expertise to the next level and contribute to the safety of medical devices worldwide, we want to hear from you.
Apply today and help shape the future of medical device compliance!
