Medical device QA/RA Consultant

2 weeks ago

Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

Radiobotics Copenhagen Freelance Part-time

Salary Competitive

This is a temporary consultancy position to support while we search for a permanent hire
Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you are a seasoned QA specialist that would like to endeavour into the field of medical device software. If that is the case, then you could be the colleague we are looking for.

You will help define and deliver on our strategy to maintain superior product quality and take lead on placing our products on new markets
As a QA/RA specialist in Radiobotics you will become the expert in all corners of our Quality Management System. You will be engaged in all stages of product development and help define structure of the technical documentation, as well as ensuring our internal quality processes are well-oiled. You will play a central role in placing products into new markets, be pivotal in maintaining our products in existing markets and you will take part in audits from notified bodies and authorities.

Your main tasks will be:

  • Co-driving product release projects in collaboration with the project manager from the development team
  • Supporting other departments in design control
  • Take lead on the risk analysis for new products, with support from our clinical and development team
  • Reviewing and revising QMS procedures to ensure that they are efficient and effective
  • Assist management in prioritizing regulatory approval activities based on strategy and market potentials
  • Creating and coordinating the product submissions for the devices we develop (possibly supported by consultants)
  • Training of the company in QMS procedures
  • Participate in audits, both internal and external

Qualifications
You have at least 1 year experience within quality assurance and/or regulatory affairs, and you know that working with quality and regulatory processes within the medical device field is the right path for you. You pay great attention to detail and your ability to structure your tasks efficiently means that you deliver on time.

The ideal candidate will furthermore have:

  • A master's degree in healthcare, medical or life science
  • A positive can-do attitude with a thorough and structured mindset
  • Excellent communication skills in English and experience with working within or leading cross-functional projects
  • Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, and ideally 21 CFR
  • Experience with Software as a Medical Device

You will join the Clinical and Regulatory team and will be referring to our Chief Clinical and Scientific Officer. We are looking for someone who can work both independently, and as part of a cross-functional team, in a changing and dynamic environment with tight deadlines. You should be good at planning, coordinating and managing stakeholders during design and development activities and product submissions.

We are Radiobotics
At Radiobotics we do what we say. To us that's integrity. We also believe in transparency. In always keeping our doors open and communicating with honesty. We are driven by aspiration, curiosity and playfulness. Because we are not afraid of pursuing big ideas. We strive to learn what happens beyond the surface. And we show up every day, ready to engage and have fun with each other. This is us. We are Radiobotics.

We are on a mission to solve the global need for radiologists while ensuring every patient receives expert level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and 1st line reported by our products. This will enable the reading of radiology images by non-specialists assisted by our products and ensure that patients have access to immediate expert-level evaluation of their imaging and ultimately facilitate that non-critical imaging is safely and effectively handled outside the hospital.

For more information or questions please contact us at nicola@thehub.io

Perks and benefits
This job comes with several perks and benefits:

  • Flexible working hours
  • Free coffee / tea
  • Social gatherings
  • Free office snacks
  • Free Friday beers
  • Near public transit
#J-18808-Ljbffr

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