[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 mindsetBenefits• 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 professionalsCompany 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 isCompany 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