Assessor - Non-active devices

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About the role

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.

We are seeking a highly skilled and knowledgeable Medical Device Regulatory Assessor and technical reviewer (final reviewer) to join our team. The successful candidate will be responsible for performing assessments of technical documentation for both non-active and active medical devices in accordance with the Medical Device Regulation (MDR) and the processes defined by the DNV Quality Management System. This role involves also thorough review of assessment reports and relevant technical documentation to ensure accuracy and compliance, as well as effective communication with customers and internal assessors on various technical issues and requirements.

What we offer

• 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 a proud equal-opportunity employer committed to building an inclusive and diverse workforce. All employment is decided on the basis of qualifications, merit, or business need, without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. DNV is committed to ensuring equal employment opportunity, including providing reasonable accommodations to individuals with a disability. US applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may contact the North America Recruitment Department (hrrecruitment.northamerica@dnv.com). Information received relating to accommodations will be addressed confidentially.

About you

Key Responsibilities:

• Perform comprehensive assessments of technical documentation provided by legal manufacturers of medical devices.
• Ensure compliance with Medical Device Regulation (MDR) and DNV Quality Management System process requirements.
• Review assessment reports and related technical documentation for accuracy and adherence to regulatory standards.
• Communicate effectively with customers and DNV Market unit assessors regarding requirements, status updates, and technical issues.
• Provide detailed and accurate reporting of assessment findings.

Qualifications:

• MSc or PhD degree in a relevant field such as:
  • Biology or Microbiology
  • Biomechanical Engineering
  • Chemistry or Biochemistry
  • Dentistry
  • Human Physiology
  • Materials or Biomaterials Science
  • Medical Technology
  • Medicine, Veterinary Medicine
  • Nursing
  • Pharmacy, Pharmacology, Toxicology
  • Physics or Biophysics
  • Physiology
  • Polymer or Metal Materials
  • Electrical, Electronics, Mechanical, or Bioengineering
  • Computer and Software Technology/AI

Work Experience:

• Minimum 4 years of work experience in the medical device manufacturing sector.
• At least two years of experience must be in design, scientific aspects, manufacturing, testing, or the use of medical devices.