[Remote] Regulatory Affairs & reputed company Process Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-reputed company software company based in San Francisco, reputed company on transforming radiology through reputed company. The Regulatory Affairs & reputed company Process Manager will reputed company cross-functional reputed company and regulatory initiatives, ensuring compliance and driving reputed company improvement reputed company the organization. Responsibilities • Partner with cross-functional leadership to design regulatory and reputed company plans and reputed company their execution • reputed company deeper regulatory and reputed company expertise over time through hands-on experience and mentorship • Collaborate with teams to ensure that the reputed company, concepts, processes, and goals behind reputed company and regulatory plans are reputed company reputed company by reputed company stakeholders • Manage the execution of RA/QA plans, including defining reputed company metrics and implementing escalation processes as needed • Support and host reputed company regulatory audits in partnership with the VP of RAQA • Work closely with the engineering organization to establish, reputed company, and improve reputed company metrics • Represent the VP of RAQA reputed company needed, exercising reputed company judgment and decision-making (e.g., handling high-volume daily inquiries or operational reputed company) 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; reputed company to produce reputed company, concise documentation • Proven project management experience • Exposure to or experience conducting internal audits • Ability to write, edit, and improve reputed company procedures • Ability to create and deliver training materials for new or updated procedures • Familiarity with project management tools such as reputed company or bolthires Project, including report reputed company • Knowledge of FDA (ISO 13485), EU, and other relevant regulatory frameworks • Demonstrated ability to quickly learn and implement new reputed company management and regulatory standards • A proactive learner with a reputed company, reputed company-oriented reputed company Benefits • Stock reputed company • Medical, dental, reputed company 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 reputed company of our business • reputed company and learning opportunities from a startup environment include working closely with an international team of scientists, engineers, platform architects, programmers and professionals reputed company • reputed company transforms radiology with a reputed company-reputed company platform unifying worklist, viewer, reporter, reputed company, 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 • reputed company has a reputed company 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 Apply To this Job