Current jobs related to Medical device QA/RA specialist - Copenhagen, Copenhagen - Radiobotics ApS

  • Medical Device Quality Assurance Specialist

    3 weeks ago

    Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    Join Our Team as a Medical Device QA/RA SpecialistWe are seeking a highly skilled and experienced Medical Device QA/RA Specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices.About the RoleAs a Medical Device QA/RA Specialist, you...

  • Medical Device Quality Assurance Specialist

    1 month ago

    Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    Join Our Team as a Medical Device QA/RA SpecialistWe are seeking a highly skilled and experienced Medical Device QA/RA Specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices.About the RoleAs a Medical Device QA/RA Specialist, you...

  • Medical Device Quality Assurance Specialist

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Job Title: Medical Device QA/RA SpecialistRadiobotics Copenhagen is seeking a highly skilled Medical Device QA/RA Specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a crucial role in maintaining superior product quality and ensuring compliance with regulatory requirements.About the Role:As a Medical Device QA/RA...

  • Medical Device Quality Assurance Specialist

    2 months ago

    Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    Job Title: Medical Device QA/RA SpecialistWe are seeking a highly skilled Medical Device QA/RA Specialist to join our Clinical and Regulatory team. As a key member of our team, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.Key Responsibilities:Develop and implement quality management systems to ensure...

  • Medical Device Quality Assurance Specialist

    4 weeks ago

    Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    Job Title: Medical Device QA/RA ConsultantThis is a temporary consultancy position to support the company's search for a permanent hire. We are looking for a highly skilled and experienced QA/RA professional to join our Clinical and Regulatory team.About the Role:The successful candidate will be responsible for defining and delivering on our strategy to...

  • Medical Device Quality Assurance Specialist

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Job Title: Medical Device QA/RA ConsultantRadiobotics Copenhagen is seeking a highly skilled Medical Device QA/RA Consultant to join our Clinical and Regulatory team. As a key member of our team, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices.About the Role:We are looking for a seasoned QA/RA...

  • Medical Device Quality Assurance Specialist

    3 days ago

    Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    A challenging opportunity has arisen at Radiobotics for a highly motivated and experienced QA/RA specialist to join our Clinical and Regulatory team. This role will be responsible for defining and delivering on our strategy to maintain superior product quality and place our products in new markets.Main Responsibilities:Co-driving product release projects in...

  • Danish Speaking QA/QMS Specialist

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    Radiometer Danmark / Danaher is seeking a highly skilled Danish speaking QA/QMS Specialist to join our team. As a key member of our Quality Management System team, you will be responsible for ensuring compliance with regulatory requirements and industry standards.This role will involve handling quality management processes, supporting processes, and...

  • Danish Speaking QA/QMS Specialist

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    About Radiometer Danmark / DanaherRadiometer Danmark / Danaher is a leading company in the diagnostics industry, committed to improving global healthcare with reliable, fast, and easy patient diagnoses. Our vision is to make a difference in people's lives by providing innovative solutions that address the world's biggest health challenges.Job Title: Danish...

  • Danish Speaking QA/QMS Specialist

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    Radiometer Danmark / Danaher is seeking a highly skilled QA/QMS Specialist to join our team. As a Danish speaking expert, you will play a crucial role in ensuring compliance with quality management systems and supporting processes within our organization.This is a unique opportunity to work in a fast-paced environment, collaborating with cross-functional...

  • Medical Device Quality Assurance Specialist

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Job Title: Medical Device Quality Assurance SpecialistJob Summary: We are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team at Radiobotics. The successful candidate will be responsible for ensuring the quality and regulatory compliance of our medical devices.Key Responsibilities:Develop and implement quality management...

  • Medical Device Regulatory Specialist

    3 days ago

    Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    {"Qualifications and Responsibilities": "We are looking for a skilled Medical Device Regulatory Specialist to join our Clinical and Regulatory team. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with a focus on medical devices.The successful candidate will possess a master's degree in a relevant field and have...

  • Senior Project Engineer

    3 days ago

    Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full time

    Be Part of a Groundbreaking TeamFerrosan Medical Devices A/S is a pioneering company in the medical devices industry, and we're seeking a skilled Senior Project Engineer to join our team. As a key member of our Technology Innovation department, you'll play a crucial role in specifying next-generation manufacturing equipment for our out-sourced manufacturing...

  • Medical Device Quality Assurance Specialist

    3 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...

  • Medical Device Quality Assurance Specialist

    2 weeks ago

    Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    Job DescriptionWe are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team. As a key member of our Clinical and Regulatory team, you will be responsible for ensuring the quality and compliance of our medical devices.Key Responsibilities:Develop and implement quality management systems to ensure compliance with regulatory...

  • Medical Device Quality Assurance Specialist

    3 days ago

    Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    About the JobWe are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team. As a key member of our Clinical and Regulatory department, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.Your primary focus will be on defining and delivering our strategy to maintain superior product...

  • Medical Device Risk Specialist

    3 days ago

    Copenhagen, Copenhagen, Denmark 3Shape Full time

    Risk Management Expert for Dental Scanning SystemsWe are seeking a highly skilled Risk Management professional to join our team and contribute to the development of scanner systems for the medical device domain. As a Risk Manager, you will play a crucial role in ensuring the safety and efficacy of our products.Your primary responsibility will be to work on...

  • Medical Device Quality Assurance Specialist

    3 weeks ago

    Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    About the RoleWe are seeking a highly skilled and experienced Quality Assurance/Regulatory Affairs professional to join our Clinical and Regulatory team. As a key member of our team, you will play a critical role in ensuring the quality and regulatory compliance of our medical devices.Key ResponsibilitiesDevelop and implement quality management systems and...

  • Risk Management Specialist for Medical Device Development

    3 weeks ago

    Copenhagen, Copenhagen, Denmark 3Shape Full time

    About the RoleWe are seeking a highly skilled Risk Manager to join our team and contribute to the development of our scanner systems, a combination of hardware and software systems in the medical device domain.As a Risk Manager, you will be responsible for working on Risk Management of our scanner systems, collaborating with colleagues across R&D, product...

  • Medical Devices Lifecycle Management Director

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Internetwork Expert Full time

    Transform Lives with Innovative Healthcare SolutionsWe are seeking an experienced Associate Director Medical Devices Lifecycle Management to join our Regulatory team at Norgine. As a key member of our team, you will be responsible for the strategic lifecycle management of our Medical Devices post CE approval and the operational execution management with our...

Medical device QA/RA specialist

3 months ago

Copenhagen, Copenhagen, 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 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

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 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