Regulatory Affairs & Quality Process Manager

About Sirona Medical

At Sirona Medical, we’re building software that enables physicians to work as fast as they can think.

Each year in the U.S., billions of patient images are captured—and nearly all of them are reviewed and diagnosed by radiologists. These specialists are the central hub of diagnostic medicine: over 80% of all healthcare data flows through radiology IT systems. Yet despite their pivotal role, radiologists are overburdened by outdated, fragmented software which limits their efficiency and ultimately the quality and efficiency of care that health systems can provide patients. That’s where Sirona comes in.

We’re a San Francisco-based, cloud-native software company with employees around the world. Our deep understanding of both the practice and business of radiology has allowed us to build RadOS—a unified, AI-powered operating system powering the entire radiology workflows.

Sirona is uniquely positioned to transform the way radiology is practiced. We're delivering the organizational shift that both individual radiologists and entire practices urgently need:

• A unified, intuitive, and platform-agnostic solution

• A streamlined workspace that makes every part of the radiologist’s workflow faster and easier

• The freedom to read from anywhere, for anyone

By cutting clicks, optimizing diagnostic time, and unlocking efficiencies that extend far beyond the reading room into all care settings, Sirona empowers radiologists—and in doing so, we help the entire healthcare system move faster, smarter, and with greater impact on patient outcomes.

For more information, please visit https://sironamedical.com/join/.

The Regulatory Affairs & Quality Process Manager (“RAQPM”) at Sirona will help teams execute on quality and regulatory guidance, identify and solve quality-related problems, and drive continuous improvement. This person will lead the execution of cross-functional quality and regulatory initiatives and serve as a key representative and support partner to the VP of Regulatory Affairs and Quality Assurance. 

• Partner with cross-functional leadership to design regulatory and quality plans and lead their execution
• Develop deeper regulatory and quality expertise over time through hands-on experience and mentorship
• Collaborate with teams to ensure that the intent, concepts, processes, and goals behind quality and regulatory plans are clearly understood by all stakeholders
• Manage the execution of RA/QA plans, including defining progress metrics and implementing escalation processes as needed
• Support and host internal and external regulatory audits in partnership with the VP of RAQA
• Work closely with the engineering organization to establish, track, and improve quality metrics
• Represent the VP of RAQA when needed, exercising sound judgment and decision-making (e.g., handling high-volume daily inquiries or operational decisions)

• 5+ years of industry experience, ideally in software or technology-driven environments.
• Working knowledge of FDA medical device regulations (Class I and/or II)
• Strong organizational and communication skills; able to produce clear, concise documentation
• Proven project management experience
• Exposure to or experience conducting internal audits
• Ability to write, edit, and improve quality procedures
• Ability to create and deliver training materials for new or updated procedures
• Familiarity with project management tools such as Asana or Microsoft Project, including report generation
• Knowledge of FDA (ISO 13485), EU, and other relevant regulatory frameworks
• Demonstrated ability to quickly learn and implement new quality management and regulatory standards
• A proactive learner with a positive, growth-oriented mindset

Benefits:

• Stock Options
• Unlimited PTO
• Medical, dental, vision insurance
• Life insurance
• Maternity and Paternity Leave
• 401K matching
• Apple equipment
• Sponsorship for conferences, continuing education, etc
• Dynamic engineering role–technological innovation is at the core of our business
• Growth and learning opportunities from a startup environment include working closely with an international team of scientists, engineers, platform architects, programmers and professionals
• Do something morally benevolent!

The annual US base salary range for this full-time position is $130,000 - $160,000 + equity + benefits. Pay scale is flexible depending on experience. Within the range, individual pay is determined by work location and additional factors, including job-related skills, competencies, experience, relevant education and training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.