ORION SEARCH INTERNATIONAL AS
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DNV GL Nemko Presafe is a joint venture by the two global organizations - DNV GL Business Assurance and Nemko. We cooperate with our owners and other partners to provide our services globally.

Our business area of Medical Devices is rapidly growing and we are therefore expanding. Our services cover the assessment for CE marking of the design and manufacturing of Medical Devices in accordance with the EU directive for Medical Devices, and certification of quality management systems in accordance with ISO 13485. We offer our services worldwide with our main markets in Europe USA, Canada and Asia.

As we continue to grow, we currently have exciting opportunities for talented individuals to join our team.

Are you looking for a career change and new challenges?

Medical Device Assessor:
As Medical Assessor you will:
  • Evaluate the product design in accordance with the Medical Device Directive and relevant standards
  • Assess the technical documentation/design file of the manufacturer to check that the documentation is in compliance with the requirements
  • Work closely with our international partner network
With a background in either:
Biomaterials / Medical Engineering / Engineering / Electronics / Physics / Chemistry / Biology / Pharmacy / Materials

You should have:
Minimum of 4 year’s experience in the medical device related field, with at least 2 years related to specific product related tasks and hands on experience with manufacturing, design, clinical evaluation and research, installation and servicing, testing experience, etc.
  • Experience with biocompatibility testing is advantageous, but not essential
  • Experience with biomaterials and surface treatment is advantageous, but not essential
  • Familiarity with ISO 13485 and Medical Device Directive is advantageous, but not essential
  • Familiarity with Clinical Investigations including ISO 14155 is advantageous, but not essential.

Or Medicine / Nursing / Dentistry

You should have:
Minimum 4 years clinical experience with at least 2 years specialised in an area of medicine / dentistry or other relevant experience with a wide range of devices.

  • Experience with biocompatibility testing is advantageous, but not essential
  • Experience with biomaterials and surface treatment is advantageous, but not essential
  • Familiarity with ISO 13485 and Medical Device Directive is advantageous, but not essential
  • Familiarity with Clinical Investigations including ISO 14155 is advantageous, but not essential.
Additional qualifications:
  • Skilled with customer relations
  • Fluent in both English and a Scandinavian language
  • Excellent writing skills
  • Excellent IT understanding
Personal characteristics:
For the role of Medical Device Assessors you should have a nose for detail, show initiative, work independently, with a passion to improve, taking pride in your work and be methodical in your practice.
DNV GL Nemko Presafe offers:
  • Varied tasks and technically challenging assignments
  • A team of highly skilled colleagues
  • An international company owned by two strong "brands", known for integrity, quality and good values
  • International network
  • Competitive terms

For further information on the position and the company, you are welcome to contact Orion Search International AS, Kristian Knudsen, tel: +47 928 00 000.

  • Søknadsfrist:
  • ASAP
  • Arbeidssted :
  • Oslo
  • Kontaktpersoner:
  • Kristian Knudsen
    Tittel: Partner, Orion Search Int. AS
    mob: 928 00 000
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