Regulatory Affairs 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 Yet despite their pivotal role, radiologists are overburdened by outdated, fragmented software which limits their efficiency and ultimately the quality and efficiency of care that health systems can provide patients.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.

How Sirona Solves the Problem

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 Manager (“RAM”) at Sirona will help build a comprehensive, global regulatory system, support teams in executing quality and regulatory guidance, identify and resolve regulatory-related issues, and drive continuous improvement. This individual will lead the execution of cross-functional regulatory initiatives and serve as a key representative and partner to the VP of Regulatory Affairs and Quality Assurance.

Key Responsibilities:

• Partner with leadership and product managers to establish medical device classifications. Execute related plans to obtain required regulatory clearances or approvals in a timely manner

• Leverage external regulatory firms to design regulatory strategies and lead internal execution

• Determine regulatory requirements for selling and marketing Sirona medical devices globally, including local device classification, registrations, and in-country representation with appropriate partners

• Host audits and inspections conducted by U.S. and global regulatory agencies or standards bodies

• Collaborate cross-functionally to ensure regulatory requirements, concepts, processes, and objectives are clearly understood by all stakeholders

• Manage execution of regulatory affairs plans, including defining progress metrics and implementing escalation processes as needed

• Define and execute required regulatory certifications and MDSAP plans

• Host internal audits and regulatory inspections in partnership with the VP of RAQA

• Work closely with the engineering organization to establish, track, and continuously improve regulatory metrics

• Develop deeper regulatory and quality expertise through hands-on experience and mentorship

• Represent the VP of RAQA as needed, exercising sound judgment and decision-making (e.g., managing high-volume inquiries or operational decisions)

• Maintain a global regulatory watch and advise the business accordingly

Key Requirements:

• 7+ years of medical device regulatory experience, preferably in software or technology-driven environments

• Working knowledge of FDA medical device regulations (Class I and/or II), EU MDR, and global regulatory standards, including ISO 13485

• Strong organizational and communication skills, with the ability to produce clear, concise, and well-maintained documentation

• Experience conducting internal audits or supporting audit activities

• Experience hosting audits and regulatory inspections

• Ability to write, edit, and improve quality and regulatory procedures covering the full product lifecycle from pre-market through post-market

• Ability to create and deliver training materials for new or updated procedures

• Demonstrated ability to quickly learn and implement new quality management and regulatory standards

• A proactive self-starter with a positive, growth-oriented mindset

Benefits

• Stock Options

• Medical, dental, vision insurance

• Life insurance

• Maternity and Paternity Leave

• Flexible time off

• 401K matching

• MacBook Pro

• Sponsorship for conferences, continuing education, etc.

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.