Company & Business Area Description
DNV GL is a global quality assurance and risk management company. Driven by our purpose of safeguarding life, property and the environment, we enable our customers to advance the safety and sustainability of their business.
We provide classification, technical assurance, software and independent expert advisory services to the maritime, oil & gas, power and renewables industries. We also provide certification, supply chain and data management services to customers across a wide range of industries.
Combining technical, digital and operational expertise, risk methodology and in-depth industry knowledge, we empower our customers’ decisions and actions with trust and confidence. We continuously invest in research and collaborative innovation to provide customers and society with operational and technological foresight.
With origins stretching back to 1864 and operations in more than 100 countries, our experts are dedicated to helping customers make the world safer, smarter and greener.
DNV GL is one of the world’s leading certification bodies. We help businesses assure the performance of their organizations, products, people, facilities and supply chains through certification, verification, assessment, and training services. Partnering with our customers, we build sustainable business performance and create stakeholder trust across all types of industries.
Local Unit & Position Description
DNV GL Presafe A/S
is a Notified Body for the Medical Device Regulation. The Section decides upon certification according to the requirements given in the Medical Device Regulation based on the assessment of the legal manufacturers' technical documentation (including clinical data) for the medical device.
Main tasks in this role are
As an Internal Clinician
you will be responsible for:
- Approval of Certification Proposals for medical devices to be certified according to the Medical Device Regulation
- Performing assessment and preparing reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the Medical Device Regulation
- Evaluation of the summary of safety and clinical performance reports for high risk medical devices
- Review and approval of clinical evaluation report and other relevant clinical documentation for accuracy and compliance with the requirements in the Medical Device Regulation
- Recommend for certification based on reviewed documentation
- Communication with the customers with regards to requirements, status and clinically relevant aspects
- Plan and execute assessment of clinical data as required, within agreed timescales and economic budget
- Medical Doctor
- At least 2 years of working experience including:
- direct work experience in patient care
- research experience in conducting preclinical or clinical trials or assessing clinical data
- Strong written and verbal English communication skills
- Strong technical skills
- Analytical approach
- Good communication skills
- Customer focus
- Excellent reporting skills
- Ability to work independently and efficiently
- Ability to recommend on certification in complex cases
- A competitive compensation and benefit package
- DNV GL training and qualification program
- A professional community in a prestigious technological company
- Possibilities to work with interesting and challenging projects
- Access to an extensive competence network
For more information, please contact Global Clinical Affairs Manager Alexey Shiryaev, + 47 912 48 469, Managing Director Cecilie Gudesen Torp, +47 416 16 969 or Bjørg Synnøve Nesgård, Operations Manager at +47 41542397.
Equal Opportunity Statement
DNV GL 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!