Regulatory Affairs Consultant for Medical Devices
3 days ago
Radiobotics ApS is a pioneering company in the field of medical devices, committed to solving 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 first-line reported by our products.
We are seeking a Regulatory Affairs Consultant for Medical Devices to join our Clinical and Regulatory team. As a key member of our team, you will be responsible for 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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Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeJob Description:We are looking for a Regulatory Affairs Expert for Medical Devices to join our Clinical and Regulatory team. The ideal candidate will have a strong background in regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest regulatory standards and that we comply with...
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