Medical device QA/RA specialist

3 days ago

Århus, Århus Kommune, Denmark The HubDanske Bank Full time

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 the 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.
  • Taking 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.
  • Assisting 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.
  • Participating in audits, both internal and external.

After two weeks...

You'll already know all your new colleagues, who do what within Radiobotics, and who can help you out when you feel lost. Moreover, you will have enjoyed a few delicious breakfasts and Friday bars. You'll be up and running with your new computer and will be familiar with our products and previous QA/RA projects.

After 1 month…

You'll be working on the first design control project, and perhaps participate in risk management activities. You will have had a few 1:1 meetings with your manager and your latte art game will be on point. You'll start naming everything in your life with the RB prefix (like our products).

After 3 months...

You'll be participating in audits, driving CAPAs and communication with authorities across the world. You will also have a plan for further development of your professional quality and regulatory affairs skillset. You will have participated in a few RB activities outside the office and have your personal ranking of your favorite almond croissants in the city.

After 6 months...

By this date, you won't be the RBrookie anymore, so you'll be the lead in our technical documentation and have reviewed and approved most types of procedures and quality records. You have played a significant role in our strategy to reach new markets and will be the go-to person for questions around topics like product submissions, validation efforts, and record control. Depending on the timing, you'll have attended a work-away, won an RBmusic-quiz, and you will have developed competitive Foosball/Petanque skills you didn't know you had.

Qualifications

You have at least 1 year of 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.

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