Current jobs related to Medical device QA/RA specialist - Copenhagen, Copenhagen - Radiobotics ApS
-
Copenhagen, Copenhagen, Denmark beBee Careers Full timeThis is a temporary consultancy position to support the Clinical and Regulatory team while they search for a permanent Quality Assurance/Regulatory Affairs specialist.The ideal candidate will have a flair for product quality and be curious to see if they can put their QA/RA experience to work and place products in new markets.Main ResponsibilitiesCo-driving...
-
Medical Device Quality Assurance Expert
2 days ago
Copenhagen, Copenhagen, Denmark beBee Careers Full timeRadiobotics is seeking a highly skilled QA/RA specialist to join their Clinical and Regulatory team. As a key member of the team, you will be responsible for maintaining superior product quality and leading efforts to place products on new markets.Key Responsibilities:Co-driving product release projects in collaboration with development team project...
-
Copenhagen, Copenhagen, Denmark beBee Careers Full timeAbout the RoleWe are seeking a highly motivated QA/RA specialist to join our team, who will be responsible for ensuring the quality and compliance of our medical devices. This role will involve working closely with our clinical and development teams to drive product release projects forward.The ideal candidate will have a strong understanding of quality...
-
Medical Device Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark beBee Careers Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our medical device regulatory team, you will be responsible for supporting regulatory activities for innovative medical devices.Key Responsibilities:Regulatory Compliance: Ensure compliance with MDR and other relevant...
-
Medical Devices Expert
4 days ago
Copenhagen, Copenhagen, Denmark beBee Careers Full timeAre you a skilled professional looking for a challenging role in the medical device industry? We are seeking a Senior Medical Device Professional to join our team. This is a full-time position that requires experience in working under ISO 13485, strong problem-solving and analytical skills, and a drive to succeed.This is an exciting opportunity to work with...
-
Certification Specialist for Medical Devices
1 week ago
Copenhagen, Copenhagen, Denmark beBee Careers Full timeAbout the RoleWe are seeking a skilled Certification Specialist to manage the certification process for our next-generation medical device platform.Plan and execute certification testing according to industry standards.Maintain certification status and collaborate with manufacturing partners to implement design changes.The position may evolve according to...
-
Medical Device Compliance Manager
1 week ago
Copenhagen, Copenhagen, Denmark beBee Careers Full timeJob Title: Medical Device Compliance ManagerWe are looking for a highly skilled professional to lead our Quality Management System, ensuring our products meet regulatory requirements.This role involves planning and executing audits, addressing non-conformities, coordinating QMS reviews, and maintaining process descriptions.The successful candidate will drive...
-
Copenhagen, Copenhagen, Denmark beBee Careers Full timeJob Title: Hardware Certification Specialist for Medical DevicesWe are seeking a skilled hardware certification specialist to manage the certification process for our next-generation scanning platform.About the JobThis role involves planning, identification of applicable standards, negotiation with certified bodies, and documentation capture. The ideal...
-
Regulatory Affairs Specialist
3 days ago
Copenhagen, Copenhagen, Denmark beBee Careers Full timeWe are looking for a highly skilled Quality Assurance and Regulatory Affairs specialist to join our team. As a QA/RA professional, you will be responsible for ensuring the highest level of product quality and regulatory compliance. Your expertise will be crucial in maintaining our competitive edge in the market.Your Key Responsibilities:Develop and implement...
-
Medical Device Quality Assurance Specialist
1 week ago
Copenhagen, Copenhagen, Denmark beBee Careers Full timeOur company is seeking a Medical Device Quality Assurance Specialist to support our product development and regulatory affairs efforts. As a key member of our Clinical and Regulatory team, you will play a central role in maintaining superior product quality and taking the lead on placing our products in new markets.Main Responsibilities:Co-driving product...
Medical device QA/RA specialist
2 weeks ago
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 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 the company in QMS procedures
- Participating in audits, both internal and external
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.
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
