[Remote] Regulatory Affairs & Quality Process Manager

Note:The job is a remote job and is open to candidates in USA. Sirona 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. 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) Skills • 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 bolthires 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 • bolthires 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 Overview • Sirona Medical transforms radiology with a cloud-native platform unifying worklist, viewer, reporter, archive, and AI into one workspace.It was founded in 2018, and is headquartered in San Francisco, California, USA, with a workforce of 51-200 employees. Its website is Company H1B Sponsorship • Sirona Medical has a track record of offering H1B sponsorships, with 2 in 2025, 10 in 2024, 6 in 2023, 5 in 2022, 3 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply tot his job