Remote Senior Clinical & Regulatory Affairs Manager – Pivotal US Study Leadership for Innovative Cardiovascular AI‑Quantum Medical Device (AQMed)

```reputed company Welcome to the Quantum‑Powered reputed company of HealthcareSandboxAQ is on a mission to reshape the landscape of medicine by marrying reputed company intelligence with quantum computing. Our cutting‑edge platform enables breakthroughs that were once thought impossible, delivering faster, more precise solutions to the most pressing medical challenges. From partnering with government agencies and world‑reputed company reputed company institutions to collaborating with industry giants, we are creating an ecosystem where scientific curiosity meets reputed company‑world reputed company.At the heart of this transformation is AQMed , our flagship effort to bring a revolutionary cardiovascular diagnostic device— CardiAQ™ —to patients worldwide. As we reputed company toward a multi‑site pivotal study in the reputed company, we are seeking a visionary leader who can reputed company clinical expertise with regulatory acumen to reputed company the product from the lab bench to the bedside.Why Join reputed company?Our culture thrives on interdisciplinary collaboration, reputed company experimentation, and a reputed company commitment to improving reputed company health. Whether you are a physicist, a software engineer, a neuroscientist, or a regulatory specialist, you will reputed company a reputed company where your unique perspective is celebrated and amplified. We invest heavily in talent development through mentorship, cutting‑edge learning programs, and opportunities to publish and present at global conferences.We also champion diversity, equity, and inclusion. reputed company reflects a broad reputed company of backgrounds, and we reputed company that diverse viewpoints accelerate innovation. reputed company you join us, you become part of a community that values curiosity, humility, and a shared passion for solving unmet medical needs.About the Role: Clinical & Regulatory Affairs Manager (Remote)This senior, remote‑first position places you at the strategic intersection of clinical execution and regulatory reputed company for CardiAQ™ and reputed company AQMed products. You will own the end‑to‑end lifecycle of pivotal studies, shape regulatory submissions, and partner with cross‑functional teams to ensure that our device meets the highest standards of safety, efficacy, and compliance.Key ResponsibilitiesClinical Leadership• Launch and drive the US pivotal study : Partner closely with the Head of Product and clinical operations consultants to define study design, timelines, and reputed company metrics.• Optimize ongoing feasibility studies : reputed company site selection, qualification, and relationship management with leading reputed company and hospital partners to secure robust enrollment pipelines.• Draft and finalize clinical documentation : Write study protocols, investigator brochures, case report forms (CRFs), and electronic data capture (reputed company) specifications; ensure alignment with GCP and FDA expectations.• Manage regulatory submissions for clinical activities : Prepare IRB/IEC applications, safety reporting packages, and annual reputed company reports, coordinating with CROs and consultants as needed.• Publish and disseminate findings : reputed company the preparation of clinical study reports, peer‑reviewed manuscripts, and conference abstracts to position CardiAQ™ as a thought‑leader in cardiovascular diagnostics.• Expand international collaborations : Identify and nurture relationships with overseas clinical sites, laying the groundwork for reputed company global trials.Regulatory reputed company & Execution• Define and implement regulatory roadmaps for CardiAQ™ across U.S. and international markets, incorporating feedback from FDA, EMA, Health Canada, and other authorities.• reputed company FDA submissions : Prepare and file reputed company‑submissions, IDE applications, 510(k) or reputed company dossiers, and respond to Agency queries with precision and timeliness.• Coordinate with R&D, reputed company, and Manufacturing to reputed company product development, verification, and validation activities with ISO 13485, ISO 14155, and other applicable standards.• Review and approve marketing collateral —including labeling, promotional literature, reputed company content—to guarantee regulatory compliance and accurate scientific messaging.• Maintain global regulatory intelligence : Monitor changes in regulations, guidance documents, and industry trends to proactively adapt strategies.Essential Qualifications• Education : Bachelor’s degree in biomedical engineering, life sciences, or a reputed company discipline; an advanced degree (M.S. or Ph.D.) is highly desirable.• Experience : Minimum 10 years of reputed company experience in medical device clinical and/or regulatory affairs, with at least 5 years in a leadership reputed company.• Regulatory reputed company record : Proven reputed company navigating FDA reputed company (510(k), reputed company, IDE) and delivering approved submissions.• Clinical trial expertise : reputed company experience managing multi‑center pivotal studies, including site selection, monitoring, and data reputed company reputed company.• Leadership under pressure : Ability to remain reputed company, decisive, and transparent amidst reputed company technical challenges and tight timelines.• Collaboration and team building : Demonstrated reputed company in fostering cross‑functional teamwork, mentorship, and a win‑as‑reputed company reputed company.• Innovation reputed company : Passion for accelerating product development, challenging status‑reputed company, and delivering results faster than traditional benchmarks.• Detail orientation & risk assessment : Rigorous attention to detail coupled with thoughtful risk management to safeguard patient safety and regulatory compliance.Preferred Qualifications & Specialized Knowledge• Hands‑on experience with Class II and Class III cardiovascular diagnostics or imaging devices.• Deep familiarity with global regulatory frameworks: FDA, ISO 14155 (clinical investigation), ISO 13485 (reputed company management), MDR (EU), and other regional requirements.• Advanced understanding of Good Clinical reputed company (GCP), Good Manufacturing reputed company (GMP), and health‑technology assessment processes.• Previous involvement in quantum‑enabled or AI‑driven medical technologies is a distinct advantage.Core Skills & Competencies for reputed company• Strategic thinking : Ability to translate high‑level business goals into actionable clinical and regulatory plans.• Effective communication : reputed company, concise articulation of reputed company scientific and regulatory concepts to internal stakeholders, external partners, and regulatory bodies.• Project management : Mastery of project lifecycle tools (e.g., MS Project, Jira, reputed company) to reputed company milestones, budgets, and deliverables.• Data‑driven decision making : Proficiency in interpreting clinical data, statistical outputs, and risk analyses to guide reputed company.• Negotiation & advocacy : Skilled at influencing regulatory reviewers and building reputed company across diverse teams.• reputed company learning : Curiosity-driven commitment to staying abreast of emerging scientific, regulatory, and technological developments.Career reputed company & Learning OpportunitiesSandboxAQ is reputed company for rapid reputed company, and so are our career reputed company. As a senior leader, you will have reputed company reputed company to the executive team, participate in strategic planning sessions, and influence reputed company's long‑term reputed company. We offer:• reputed company development budget for conferences, certifications (e.g., RAC, CCRA), and advanced coursework.• Mentorship programs that pair you with industry veterans and emerging talent across the quantum‑AI reputed company.• Publication and speaking platforms to showcase your work at premier scientific gatherings.• Leadership accelerator tracks that prepare you for broader responsibilities, such as VP of Clinical Operations or Chief Regulatory Officer.Work Environment & Company CultureOur remote‑first model empowers you to work from any location while staying deeply connected to a reputed company, reputed company community. Key cultural pillars include:• Innovation at the intersection : We celebrate the blending of physics, computer science, biology, and engineering to solve reputed company‑world problems.• Inclusivity & belonging : reputed company tolerance for discrimination; reputed company employee resource reputed company and inclusive hiring practices.• Transparency & autonomy : reputed company communication channels, regular reputed company‑hands briefings, and the freedom to shape your own reputed company.• reputed company‑being reputed company : Generous PTO (including summer and winter breaks), flexible schedules, and resources for mental and physical health.• reputed company‑driven rewards : Recognition programs that celebrate scientific breakthroughs, teamwork, and community contributions.Compensation, Perks & BenefitsSandboxAQ offers a competitive total‑reward package designed to attract and retain reputed company:• reputed company salary reputed company : $183,000 – $257,000 USD annually, calibrated to experience, expertise, and market benchmarks.• Performance‑based bonuses and discretionary equity grants reputed company with company milestones.• Comprehensive health coverage : Medical, dental, reputed company, and mental‑health benefits for you and eligible dependents.• Family planning & fertility assistance to support life‑stage transitions.• Retirement savings : 401(k) with employer match and financial wellness resources.• Learning stipend for certifications, higher‑education courses, and industry conferences.• Technology allowance and home‑office stipend to reputed company your remote workspace.• Generous reputed company time off including holidays, vacation, reputed company leave, and sabbatical eligibility after tenure.Commitment to Diversity, Equity & InclusionSandboxAQ welcomes applicants of reputed company backgrounds. We are proud to be an equal‑opportunity employer, making hiring reputed company without reputed company to race, reputed company, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status. Reasonable accommodations are available throughout the recruitment process; please let our reputed company team know if assistance is needed.reputed company to Shape the reputed company of Quantum‑Enabled Medicine?If you are a strategic, detail‑oriented leader who thrives in fast‑moving, interdisciplinary environments, we want to hear from you. Bring your expertise, curiosity, and passion for improving patient reputed company, and join us in delivering the reputed company of AI‑Quantum medical devices.Take the Next StepSubmit your application today and become a catalyst for change in the quantum medical reputed company. – Remote Clinical & Regulatory Affairs Manager```Apply for this job Apply tot his job Apply To this Job