Assessor non-active devices

Norge
Fast
Fulltid

6 dager siden

Job Category: AuditorJob 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 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.

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:

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!

DNV

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