Quality & Regulatory Specialist

As a Quality & Regulatory Specialist at VideaHealth, your responsibilities include shaping the software as a medical device (SaMD) Quality Management System, developing QA/RA and security software modules, and supporting regulatory submissions such as FDA clearances and CE Marks. You will work with various stakeholders to enhance quality processes and ensure compliance with relevant regulations, overseeing everything from document control to internal audits.

To be eligible for the Quality & Regulatory Specialist role at VideaHealth, a Bachelor’s Degree or higher is required, along with a minimum of 3 years of experience in a quality and regulatory position. Candidates should have experience with quality auditing, regulatory affairs, and software quality assurance, as well as strong technical writing skills and collaboration experience with stakeholders across the organization.

VideaHealth fosters a supportive work environment focused on collaboration and innovation. As a Quality & Regulatory Specialist, you'll have access to mentorship opportunities with experienced leaders in the field, giving you the chance to enhance your skills. You can tackle various challenges while contributing to groundbreaking technologies in dentistry, helping to accelerate your professional development.

Cybersecurity is a crucial aspect of the Quality & Regulatory Specialist role at VideaHealth. You will take part in driving cybersecurity management efforts by working closely with the Information Security Officer. Your expertise will be essential in ensuring compliance with cybersecurity standards and protecting electronic protected health information (ePHI), aligning software solutions with HITRUST, SOC2, HIPAA, and GDPR.

The Quality & Regulatory Specialist position at VideaHealth stands out because it merges quality and regulatory processes with cutting-edge AI technologies in dentistry. You'll have the chance to contribute directly to software that can significantly impact patient care, all while working in a fast-paced, collaborative environment that encourages creative problem-solving and innovation.

When answering this question, highlight specific experiences where you've developed, implemented, or monitored QMS processes. Discuss any relevant tools or methodologies you've used and how you've contributed to process improvements, ensuring to relate your answer to the goals of VideaHealth.

To answer this, emphasize your understanding of specific regulatory standards relevant to the medical device industry. Detail your methods for keeping up-to-date with changes in regulations and how you adapt your practices to maintain compliance, showcasing your proactive approach to regulatory affairs.

Discuss a specific project where you collaborated with teams from different departments. Focus on your role, the challenges faced, and how you effectively communicated and coordinated efforts, relating it back to the collaborative culture at VideaHealth.

Explain your approach to preparing for internal audits, including documentation review, team communication, and process refinement. You can also share how you foster a culture of readiness and continuous improvement, aligning this with VideaHealth’s focus on operational excellence.

Describe a specific regulatory submission experience, detailing your role in the project, the challenges faced, and the outcomes. Be sure to mention any relevant certifications or clearances and how this experience aligns with VideaHealth’s activities.

When responding, demonstrate your structured problem-solving methodology. Share examples of challenges you've faced and how you've analyzed situations to develop effective, sustainable solutions that can enhance quality processes.

Discuss various metrics such as compliance rates, audit findings, and CAPA effectiveness. Emphasize how these metrics inform continuous improvement and support VideaHealth’s commitment to delivering quality dental solutions.

Highlight your interpersonal skills and examples of how you've built trust and collaboration with internal and external stakeholders. Focus on your communication style and how it aligns with fostering teamwork in VideaHealth's dynamic environment.

Share specific tools or software you've utilized in your QA work, explaining how they contributed to streamlined processes and efficiency. Relate your answer to VideaHealth's focus on tech-driven solutions to enhance patient care.

This is a chance to express your passion for the industry and VideaHealth's mission. Discuss your enthusiasm for AI in healthcare, your interest in improving dental care, and how your values align with the company's commitment to innovation and quality.