Medical Device Quality Assurance Specialist

5 days ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

Job Description:

Radiobotics Copenhagen is seeking a skilled Medical Device Quality Assurance Specialist to support our product development and regulatory affairs efforts. This is a part-time, temporary consultancy position to assist with our current needs.

About the Role:

We are looking for a detail-oriented and structured professional with at least 1 year of experience in quality assurance and/or regulatory affairs, preferably in the medical device field. The ideal candidate will have a master's degree in healthcare, medical, or life science and excellent communication skills in English. They should also have experience with quality management systems, regulatory requirements within MDR and ISO 13485, and ideally 21 CFR.

Key Responsibilities:

  • Co-drive product release projects with the development team
  • Support other departments in design control
  • Lead risk analysis for new products with support from the clinical and development team
  • Review and revise QMS procedures to ensure efficiency and effectiveness
  • Assist management in prioritizing regulatory approval activities based on strategy and market potential
  • Coordinate product submissions for developed devices
  • Train the company in QMS procedures
  • Participate in audits, internal and external

Requirements:

  • At least 1 year of experience in quality assurance and/or regulatory affairs
  • Master's degree in healthcare, medical, or life science
  • Excellent communication skills in English
  • Experience with quality management systems and regulatory requirements within MDR and ISO 13485
  • Knowledge of software as a medical device

What We Offer:

  • Flexible working hours
  • Free coffee and tea
  • Social gatherings
  • Free office snacks
  • Free Friday beers
  • Near public transit

Contact Us:



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