Medical Device Quality Assurance Specialist
20 hours ago
Radiobotics ApS is seeking a highly skilled QA/RA expert to join our Clinical and Regulatory team. As a Medical Device Quality Assurance Specialist, you will play a pivotal role in ensuring the superior product quality and regulatory compliance of our medical devices.
The ideal candidate will have at least 1 year of experience in quality assurance and/or regulatory affairs, with a strong understanding of quality management systems and regulatory requirements within MDR and ISO 13485. You will be responsible for reviewing and revising QMS procedures, assisting management in prioritizing regulatory approval activities, and participating in audits.
Your main tasks will include:
- 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 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
To succeed in this role, you will need excellent communication skills in English and experience with working within or leading cross-functional projects. Knowledge of software as a medical device and a positive can-do attitude with a thorough and structured mindset are also essential.
We offer a competitive salary and a range of benefits, including flexible working hours, free coffee/tea, social gatherings, free office snacks, and free Friday beers.
At Radiobotics ApS, we believe in transparency, integrity, and pursuing big ideas. We strive to learn what happens beyond the surface and show up every day ready to engage and have fun with each other.
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Medical Device Quality Assurance Specialist
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Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeWe are seeking a highly skilled Medical Device QA/RA specialist to join our Clinical and Regulatory team at Radiobotics. This is an exciting opportunity for someone with experience in quality assurance and regulatory affairs, who is passionate about ensuring the highest standards of product quality.Company OverviewRadiobotics is a leading company in the...
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