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LOCAL UNIT & POSITION DESCRIPTION

DNV Product Assurance AS is one of the leading Notified Bodies for medical devices. Unit is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation before such products are placed on the market. 
The role of Internal Clinician is to assess clinical data supporting safety and performance of devices.
 
Main tasks in this role are:
  • 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
  • Performing competence review of new resources (clinicians)
  • Plan and execute assessment of clinical data as required, within agreed timescales and economic budget

POSITION QUALIFICATIONS

Position Qualifications:
  • 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
Personal Qualities:
  • ​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
We offer:
  • A competitive compensation and benefit package
  • DNV 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
If you are interested, please submit your CV and Cover Letter in English.
 
For more information, please contact Global Clinical Affairs Manager Alexey Shiryaev, + 47 912 48 469,  or Bjørg Synnøve Nesgård, Head Of Certification Processes at +47 41542397.


COMPANY & BUSINESS AREA DESCRIPTION

DNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.
 
We are one of the world’s leading certification, assurance and risk management providers. Whether certifying a company’s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to support our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.


EQUAL OPPORTUNITY STATEMENT

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!
Automatisk varsling av relevante stillinger eller personlig bistand i jakten på din neste jobb.
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DNV
Kontaktpersoner
Navn: Alexey Shiryaev
Tittel: Global Clinical Affairs Manager
Telefon: + 47 912 48 469
Navn: Bjørg Synnøve Nesgård
Tittel: Operations Manager
Telefon: +47 415 42 397
Arbeidssted
Veritasveien 1
1363 HØVIK