Medical Device Regulatory Affairs Expert

4 weeks ago


Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

Job Summary: We are seeking a highly skilled Medical Device Regulatory Affairs Specialist to join our team. As a key member of our Clinical and Regulatory team, you will play a critical role in maintaining superior product quality and ensuring compliance with regulatory requirements.

About Us: At Radiobotics, we are driven by aspiration, curiosity, and playfulness. We strive to learn what happens beyond the surface and show up every day, ready to engage and have fun with each other. Our mission is to solve the global need for radiologists while ensuring every patient receives expert-level care.

Key Responsibilities: Your main tasks will be to drive product release projects, support other departments in design control, take lead on risk analysis for new products, review and revise QMS procedures, assist management in prioritizing regulatory approval activities, create and coordinate product submissions, and train the company in QMS procedures.

Qualifications: To succeed in this role, you should have at least 1 year of experience within quality assurance and/or regulatory affairs, a master's degree in healthcare, medical, or life science, excellent communication skills in English, and experience with working within or leading cross-functional projects.

What We Offer: We offer a competitive salary range of $80,000 - $110,000 per year, depending on your experience and qualifications. You will also have the opportunity to work on challenging projects, collaborate with a talented team, and contribute to our mission to improve patient care.



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