Medical device QA/RA Consultant

1 day ago


København, 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

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

  • København, Denmark The HubDanske Bank Full time

    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...


  • København, Denmark Radiobotics ApS Full time

    Radiobotics Copenhagen Full-time Salary Competitive 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...


  • København, 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...


  • København, Denmark Pharmalogic Full time

    Pharmalogic – Great People – Great Place to Work Pharmalogic ApS is a small, dedicated firm offering professional consultancy services within the life science industry. We provide expertise in various areas, acting as experienced specialists or temporary employees to ensure quality and meet deadlines. Our mission is to support the industry in achieving...


  • København, Denmark Radiometer Danmark Danaher Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating...


  • København, Denmark Qmed Consulting AS Full time

    Clinical Trial Assistant (Office Based with some flexibility) – Medical Devices We are looking for our new Clinical Trial Assistant (Office Based with some flexibility) – Medical Devices Your main responsibilities will include, but are not limited to: The Clinical Trial Assistant (CTA) plays a key role within Qmed Consulting to administer, maintain and...


  • København, Denmark Radiometer Danmark Danaher Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating...


  • København, Denmark 3Shape Full time

    We are seeking a Risk Manager to contribute to developing scanner systems, a combination of hardware and software systems in the medical device domain. Your main task is working on Risk Management of our scanner systems. You will mainly work in one or more development projects, but the role also covers keeping marketed products sharp. The work on the...

  • Medical Lead

    1 day ago


    København, Denmark Novartis Full time

    About the Role Your Key Responsibilities: Your responsibilities include, but are not limited to: Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriate, for frequently asked questions. Provide medical/scientific input into the development...

  • Senior QA Engineer

    1 day ago


    København, Denmark Corti Full time

    There is no quality healthcare without a quality dialogue. Today, that dialogue is broken; we need you to help us fix it. Doctors and nurses across the world are facing unprecedented challenges. When we meet them, they're dealing with heavy workloads, extensive paperwork, and the pressure of performing well, which in healthcare, can have dire consequences....

  • Medical Advisor

    1 day ago


    København, Denmark Radiometer Danmark Danaher Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating...


  • København, Denmark Lundbeck AS, H Full time

    This is a great chance to work as a QA Academic, working with quality assurance in CMC. We provide a role collaborating with multiple stakeholders and with various responsibilities in your daily work supporting CMC deliverables from early to late phase pipeline projects. Your new role – why is this a great opportunity? You will join a growing department...


  • København, Denmark emagine Consulting AS Full time

    Join our team as a QA/CV Sourcing Specialist in Copenhagen, Denmark! Are you ready to drive impactful changes for some of the top-tier IT freelancers in Denmark and across Europe? Come aboard our dynamic Sourcing Back Office team and step into the role of a QA/CV Sourcing Specialist in the rapidly expanding IT industry! As a QA/CV Sourcing Specialist, your...

  • QA Specialist

    16 hours ago


    København, Denmark 3Shape AS Full time

    We are seeking a Quality Assurance Specialist to contribute to developing scanner systems, a combination of hardware and software systems in the medical device domain. You will work on improving the quality aspect in our development projects as part of a cross-functional team. As a Quality Assurance Specialist in 3Shape, you will be actively involved in...

  • Senior Consultant

    1 day ago


    København, Denmark Emendo Consulting Group Full time

    Are you ready to embark on an incredible journey? Do you want to become a part of a vibrant and diverse community where like-minded individuals come together to explore, learn, and grow? We are always on the lookout for motivated and talented people. Being at the Forefront of What We Do At Emendo, we believe that a fulfilled team brings their best...


  • København, Denmark Teton.ai Aps Full time

    Quality Assurance Full-time Copenhagen, DK Teton is building AI technology that empowers nurses and frontline care staff to deliver more effective care with less stress. Our solution helps hospitals and care homes maintain critical care standards and patient safety, addressing the global nursing shortage with innovative AI tools. At Teton, we operate...


  • København, Denmark STM Consulting, Inc. Full time

    Direct message the job poster from STM Consulting, Inc. Nitish Tyagi - Empowering Your Digital Workforce Strategic Hiring for Leadership roles with AIops Tech-Stack. Partnering with Client on FTE / Contract & Staff Augmentation connecting them with Top… Key Responsibilities: Leadership and Team Management: Lead, mentor, and manage a team of QA engineers...


  • København, Denmark LILT Full time

    What we are looking for Lilt is looking for English into Danish freelance translators to join our Translator Community. We are interested in the following domains: Life Sciences, Medical, Medical devices, etc. If you have experience in any other domain or subdomain, please state it clearly on your resume. Please note that this is a remote, freelance...


  • København, Denmark Globant Full time

    Company: sistemasgl We are a digitally native technology services company where innovation, design and engineering meet scale. We use some of the latest technologies in the digital and cognitive field to empower organizations in every aspect. Vertic, a Globant division, is currently looking for a Medical Writer to join its Globant Gut Studio in Copenhagen....


  • København, Denmark Københavns Universitet Full time

    The University uses third-party technologies to register user behaviour on the website (statistics) to keep improving our service. The University also uses third-party technologies to promote degree programmes, courses, conferences and exhibitions on websites and social media to show you the most relevant offers. Group Leader of Formulation Sciences &...