Medical Device Quality Specialist

4 days ago


Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time
Radiobotics Copenhagen Part-time Freelance

A competitive salary is offered for this temporary consultancy position to support our search for a permanent hire.

As a seasoned QA/RA professional, you have a flair for product quality and are eager to explore new markets. Maybe you've been working on product registrations for a while and want to delve deeper into the holistic aspects of QMS systems. Perhaps you're a skilled QA specialist looking to venture into medical device software. If that's the case, we'd love to hear from you.

Your Key Responsibilities:
  • Collaborate with the project manager from the development team to drive product release projects forward.
  • Support other departments in design control, ensuring seamless processes.
  • Leverage your expertise to lead risk analysis for new products, backed by clinical and development teams.
  • Analyze and refine QMS procedures to optimize efficiency and effectiveness.
  • Assist management in prioritizing regulatory approval activities based on strategic goals and market potential.
  • Oversee product submissions for developed devices, possibly with consultant support.
  • Provide training on QMS procedures to ensure a cohesive company-wide understanding.
  • Participate in internal and external audits, driving continuous improvement.
Requirements:
  • At least 1 year of experience in quality assurance and/or regulatory affairs, with a strong affinity for the medical device field.
  • A master's degree in healthcare, medical, or life science.
  • A positive can-do attitude paired with a structured and meticulous approach.
  • Excellent English communication skills and experience leading cross-functional projects.
  • Familiarity with quality management systems and regulatory requirements under MDR and ISO 13485, ideally including 21 CFR.
  • Experience with Software as a Medical Device.


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