Regulatory Affairs Specialist

Nanox (NASDAQ: NNOX) is a dynamic and growing organization, focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and a proprietary digital source. NanoX is a Medical Device company, developing, manufacturing and marketing Digital Tomosynthesis Systems (DTS), an X-Ray technology-based active device, with a multi-functional embedded software component, based on a Cloud platform, aiming to create the next generation of advanced 3D imaging services.

Join Us and Make an Impact!

Being a Nanoxer means becoming part of a pioneering team that’s transforming the future of healthcare. You’ll thrive in an innovative environment, pushing the boundaries of technology and AI to drive the transition to preventive healthcare. Experience growth in a fast-paced, dynamic setting, working alongside passionate professionals who value your ideas. Our innovative environment encourages creativity and collaboration, offering you the chance to grow professionally while making a meaningful impact on global health. Shape your career and the future of medical imaging with us.

We are looking for an experienced and highly motivated Regulatory Affairs Specialist who possesses technical depth and strong interpersonal skills, to join our Regulatory team. As a Regulatory Affairs Specialist, you will lead inter-disciplinary regulatory matters to support the organization compliance with applicable regulations. This will require hands-on, practical knowledge, as well as your collaboration with cross-functional teams in a multi-site organization.

Requirements:

· B.S. degree in Life Sciences or equivalent or 4+ years of professional experience in regulatory affairs of medical devices.

· 2+ years of experience in regulatory affairs of active medical devices Class II or higher is required.

· Excellent written and verbal communication skills, including proficiency in medical terminology from several disciplines (in English).

· Strong multitasking ability with impeccable attention to details.

· Strong planning, organizational, and problem-solving abilities.

Responsibilities:

· Lead PMS activities in accordance with regulatory requirements- ensure, promote, and support PMS process carried out across all relevant departments.

· Lead AMAR licensing, filings, certifications, and permits processing and monitoring.

· Lead compliance of List of Applicable Standards, including updates.

· Compile ROW (non-US or EU) regulatory submission files.

· Support clinical investigations processes.

· Coordinate Regulatory compliance in R&D activities- Risk Management, Usability and V&V, in accordance with regulatory requirements.

· Drive continuous improvement in regulatory processes and practices.