Sirona Medical · 2 months ago
Regulatory Affairs & Quality Process Manager
United States
Full-time
Remote
Senior Level
$130K/yr - $160K/yr
5+ years expSirona Medical is a cloud-native software company based in San Francisco, focused on transforming radiology through innovative solutions. The Regulatory Affairs & Quality Process Manager will lead cross-functional quality and regulatory initiatives, ensuring compliance and driving continuous improvement within the organization.
Artificial Intelligence (AI)HealthcareSoftwareHealth Care
Responsibilities
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)
Qualification
Required
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
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
Company
Sirona Medical
Sirona Medical transforms radiology with a cloud-native platform unifying worklist, viewer, reporter, archive, and AI into one workspace.
51-200 employees
H1B Sponsorship
Sirona Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (10)
2023 (6)
2022 (5)
2021 (3)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$104.5MKey Investors
Avidity PartnersGreatPoint Ventures8VC
2024-11-26Series C· $42M
2024-11-26Convertible Note
2021-11-09Series B· $40M
Leadership Team
Cameron Andrews
Founder & CEO
Mark D. Longo, Ph.D.
Chief Technology Officer (CTO)
Recent News
Medical Product Outsourcing
2025-12-12
2025-03-06
Company data provided by crunchbase