\nCompany\n\nRadNet is a public company operating 350+ medical imaging centers across the US. Its AI division - comprising subsidiaries Aidence, DeepHealth, and Quantib - develops and markets AI-based software products for the early detection of breast, lung, and prostate cancers with the purpose of bringing the world's best doctor to every patient.\n\n\nIn the AI division, we are dedicated to addressing the most complex challenges faced by radiologists and enhancing their ability to focus on valuable tasks. Medical images hold the secrets to diseases that both physicians and we aim to unveil. Our mission is to empower radiologists with fast and accurate artificial intelligence software, enabling them to detect even the subtlest changes within the human body. If you're passionate about advancing healthcare through artificial intelligence, we invite you to join our team.\nWe are not just a workplace; it's a collaborative environment where teamwork is paramount. We're a close-knit, growing team, embracing an agile approach that allows us to swiftly adapt to challenges and opportunities alike.\n\n\nRole Summary\nThe Sr. Regulatory Specialist is responsible for supporting DeepHealth’s product and product development and regulatory activities to commercialize new digital products, including AI technologies. In this role, the Sr. Regulatory Specialist will provide regulatory input on design and development activities to cross-functional teams, to ensure compliance with the relevant regulatory requirements and interactions with regulatory authorities\n\nEssential Duties and Responsibilities\n\nAs the Senior Regulatory Specialist, this position will:\n* \nRepresent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.\n* \nAssess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.\n* \nAssist in SOP development and review in support of "next-gen" product offerings.\n* \nRevisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.\n* \nUnderstand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval.\n* \nCreate and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.\n* \nAssist in preparation and review of regulatory submission to authorities.\n* \nEvaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.\n* \nUtilize technical regulatory skills to propose strategies on complex issues.\n* \nEnsure compliance with product post marketing requirements.\n* \nReview product labeling to ensure compliance with relevant regulatory requirements.\n* \nIndividual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.\n* \nWork with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes.\n\n\n\nPLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.\n\nMinimum Qualifications, Education and Experience\nQualifications include:\n\n* \nBachelor’s degree in relevant field (or equivalent experience)\n\n* \nStrong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.\n\n* \n6-8 years working in a regulated industry (FDA and Software as a Medical Device preferred).\n\n* \nKnowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings. Filings for Software as Medical Device preferred.\n\n* \nExperience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus. \n\n* \nExperience interacting with Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.\n\n* \nKnowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56.\n\n* \nKnowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred.\n\n* \nExcellent written and oral communication skills\n\n\nWorking Conditions\nThis position is may be based in the United States, European Union, or India in a typical office setting.\nThis position will have the ability to work remotely.\nPhysical Requirements\nThis position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands\nand fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to\n10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other\nforms of transportation.\n\n\nWhat We Offer\n* \nJoin a dynamic team with expertise in various fields.\n* \nCollaborative and agile work environment.\n* \nContinuous learning opportunities to enhance your professional skills.\n* \nFully remote working environment with Flexibility in work hours. \n* \nA salary in line with job level and experience.\n\n\n\n\n* At this time, the company can only support visa sponsorship between European countries. We can not support visa sponsorship internationally between the US and Europe. \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Senior and Marketing jobs that are similar:\n\n $60,000 — $130,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n