Full-Time

Clinical & Regulatory Affairs Manager

Aqmed

Confirmed live in the last 24 hours

SandboxAQ

SandboxAQ

201-500 employees

AI and quantum technology solutions provider

Consulting
Cybersecurity
AI & Machine Learning

Compensation Overview

$183k - $257kAnnually

+ Bonus + Equity

Expert

Remote in USA

Category
Legal
Risk & Compliance
Legal & Compliance
Requirements
  • You have a bachelor's degree in biomedical engineering, life sciences, or a related field; an advanced degree is preferred.
  • Minimum of 10 years of industry experience in medical devices, serving in clinical and/or regulatory affairs, with significant leadership responsibility.
  • Experience preparing regulatory submissions for the FDA, including successful approvals of 510(k) and/or de-novo.
  • Experience launching and managing multi-center pivotal studies; international site management experience is a plus.
  • In-depth knowledge of FDA regulations, ISO 14155, ISO 13485, MDR, and other global regulatory requirements.
  • Strong understanding of clinical trial regulations and Good Clinical Practice (GCP).
Responsibilities
  • Lead US pivotal study launch, working alongside the company’s Head of Product and clinical operations consultants.
  • Manage and optimize ongoing US feasibility studies to ensure strong partnerships with our leading clinical sites.
  • Write clinical study protocols and clinical study reports, emphasizing bringing key evidence to leading publications in close collaboration with our clinical partners.
  • Manage clinical research activities, including site selection & qualification, preparation of study-related documents & records (e.g. investigator’s brochure, CRF/EDC design), IRB submission and reporting, with support from consultants and/or CRO.
  • Expand and cultivate our relationships with international clinical partners.
  • Formulate, communicate, and implement regulatory strategies for the CardiAQ™ device throughout its product lifecycle, both US and OUS.
  • Lead US FDA regulatory submissions (e.g. pre-submission, BDD, IDE, 510(k), De-Novo as appropriate) and negotiation in conjunction with our regulatory consultants.
  • Collaborate with R&D, Quality, and Manufacturing to ensure the development, testing, and release processes of our product align with industry requirements and standards (e.g. ISO).
  • Review and approve labeling, advertising, and promotional materials for compliance purposes.
  • Compile and submit regulatory filings to international regulatory bodies.

SandboxAQ focuses on using Artificial Intelligence and Quantum technologies to address complex societal challenges. Their offerings include crypto-agile security, quantum sensing, and quantum simulation & optimization, which help organizations stay ahead of the curve as quantum computing evolves. By collaborating with top professional services firms, they assist clients in implementing these advanced solutions to enhance security and foster innovation. What sets SandboxAQ apart from competitors is their proactive approach in preparing businesses and governments for the future impact of quantum computing, ensuring they maintain a competitive advantage. The company's goal is to bridge the global digital divide by equipping organizations with the tools they need to thrive in a rapidly changing technological landscape.

Company Stage

Late Stage VC

Total Funding

$875.5M

Headquarters

Palo Alto, California

Founded

2021

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

28%

2 year growth

147%
Simplify Jobs

Simplify's Take

What believers are saying

  • SandboxAQ raised $300 million to expand its engineering team and quantum AI solutions.
  • Their collaboration with The Michael J. Fox Foundation aims to advance Parkinson's research.
  • Innovative GPS-free navigation using quantum sensors could revolutionize aerospace and defense.

What critics are saying

  • Increased competition in quantum tech could impact SandboxAQ's market share.
  • Rapid tech advancements may render SandboxAQ's solutions obsolete without continuous innovation.
  • Potential regulatory changes in data privacy could affect operations in sensitive sectors.

What makes SandboxAQ unique

  • SandboxAQ leverages AI and quantum tech to solve complex societal challenges.
  • Their focus on Large Quantitative Models offers industry-specific optimizations beyond traditional models.
  • They prepare companies for quantum computing's impact on innovation, competition, and security.

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