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Medical Device Regulatory Assessor and Technical Reviewer

2 months ago

Oslo, Oslo County, Norway DNV Germany Holding GmbH Full time

Job Summary:

We are seeking a highly skilled and knowledgeable Medical Device Regulatory Assessor and Technical Reviewer to join our team at DNV Germany Holding GmbH. 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 our Quality Management System.

Key Responsibilities:

  • Perform comprehensive assessments of technical documentation provided by legal manufacturers of medical devices to ensure compliance with regulatory standards.
  • Review assessment reports and related technical documentation for accuracy and adherence to regulatory requirements.
  • Communicate effectively with customers and internal 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, biomechanical engineering, chemistry, dentistry, human physiology, materials science, medical technology, medicine, veterinary medicine, nursing, pharmacy, pharmacology, toxicology, physics, biophysics, physiology, polymer or metal materials, electrical engineering, electronics, mechanical engineering, or bioengineering.
  • Minimum 4 years of work experience in the medical device manufacturing sector, with at least two years of experience in design, scientific aspects, manufacturing, testing, or the use of medical devices.

Skills:

  • Strong written and verbal English communication skills.
  • Excellent customer service skills.
  • Proficient in reporting and documentation.

About Us:

DNV Germany Holding GmbH is a designated Notified Body for Medical Device Regulation and an Accredited Certification Body for ISO 13485. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations.