Regulatory Affairs Expert for Medical Devices
3 days ago
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 all relevant regulations.
Key Responsibilities:
- Leading product release projects in collaboration with the project manager from the development team
- Providing design control support for other departments
- Conducting 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
- 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
About Us:
Radiobotics is a pioneering company that is committed to providing high-quality medical devices. Our mission is to solve the global need for radiologists while ensuring every patient receives expert-level care. We are driven by aspiration, curiosity, and playfulness, and we strive to learn what happens beyond the surface.
Requirements:
To be successful in this role, you will need to have at least 1 year of experience in regulatory affairs. You will also need to have a master's degree in healthcare, medical or life science, and excellent communication skills in English. Experience with working within or leading cross-functional projects is highly desirable.
We Offer:
In return for your hard work and dedication, we offer a competitive salary and a range of benefits, including professional development opportunities and a dynamic and supportive work environment.
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