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

```html Welcome to the Quantum‑Powered Future of Healthcare reputed company is on a mission to reshape the landscape of medicine by marrying artificial 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‑renowned academic institutions to collaborating with industry giants, we are creating an ecosystem where scientific curiosity meets real‑world impact. At the heart of this transformation is AQMed, our flagship effort to bring a revolutionary cardiovascular diagnostic device—CardiAQ™—to patients worldwide. As we move toward a multi‑site pivotal study in the United States, we are seeking a visionary leader who can reputed company clinical expertise with regulatory acumen to steer 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 human health. Whether you are a physicist, a software engineer, a neuroscientist, or a regulatory specialist, you will find 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 strategy for CardiAQ™ and future 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 Responsibilities

Clinical 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 success metrics.
• Optimize ongoing feasibility studies: reputed company site selection, qualification, and relationship management with leading academic 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 future global trials.

Regulatory Strategy & 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 pre‑submissions, IDE applications, 510(k) or De‑Novo dossiers, and respond to Agency queries with precision and timeliness.
• Coordinate with R&D, Quality, and Manufacturing to align product development, verification, and validation activities with ISO 13485, ISO 14155, and other applicable standards.
• Review and approve marketing collateral—including labeling, promotional literature, and digital 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 progressive experience in medical device clinical and/or regulatory affairs, with at least 5 years in a leadership reputed company.
• Regulatory track record: Proven success navigating FDA reputed company (510(k), De‑Novo, IDE) and delivering approved submissions.
• Clinical trial expertise: Direct 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‑a‑team 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 (quality management), MDR (EU), and other regional requirements.
• Advanced understanding of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and health‑technology assessment processes.
• Previous involvement in quantum‑enabled or AI‑driven medical technologies is a distinct advantage.

Core Skills & Competencies for Success

• Strategic thinking: Ability to translate high‑level business goals into actionable clinical and regulatory plans.
• Effective communication: Clear, 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 track milestones, budgets, and deliverables.
• Data‑driven decision making: Proficiency in interpreting clinical data, statistical outputs, and risk analyses to guide strategy.
• 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 Growth & Learning Opportunities reputed company is built for rapid evolution, and so are our career reputed company. As a senior leader, you will have direct access to the executive team, participate in strategic planning sessions, and influence the company's long‑term vision.

We offer

• Professional 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 Culture Our remote‑first model empowers you to work from any location while staying deeply connected to a vibrant, collaborative community. Key cultural pillars include:

• Innovation at the intersection: We celebrate the blending of physics, computer science, biology, and engineering to solve real‑world problems.
• Inclusivity & belonging: reputed company tolerance for discrimination; active employee resource groups and inclusive hiring practices.
• Transparency & autonomy: Open communication channels, regular reputed company‑hands briefings, and the freedom to shape your own projects.
• Well‑being focus: Generous PTO (including summer and winter breaks), flexible schedules, and resources for mental and physical health.
• Impact‑driven rewards: Recognition programs that celebrate scientific breakthroughs, teamwork, and community contributions.

Compensation, Perks & Benefits reputed company offers a competitive total‑reward package designed to attract and retain top talent:

• reputed company salary range: $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, vision, 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 paid time off including holidays, vacation, sick leave, and sabbatical eligibility after tenure.

Commitment to Diversity, Equity & Inclusion reputed company welcomes applicants of reputed company backgrounds. We are proud to be an equal‑opportunity employer, making hiring decisions without regard to race, color, 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 recruiting team know if assistance is needed. Ready to Shape the Future 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 outcomes, and join us in delivering the reputed company of AI‑Quantum medical devices. Take the reputed company Submit your application today and become a catalyst for change in the quantum medical revolution. Apply Now – Remote Clinical & Regulatory Affairs Manager ``` Apply This Job Apply tot his job Apply To this Job