Full-Time

Clinical & Regulatory Affairs Manager

Aqmed

Updated on 12/6/2024

SandboxAQ

SandboxAQ

201-500 employees

AI and quantum technology solutions provider

Cybersecurity
AI & Machine Learning

Compensation Overview

$183k - $257kAnnually

+ Annual Discretionary Bonuses + Equity

Senior

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 leverages 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 gain a competitive advantage ahead of the widespread availability of quantum computers. They collaborate with leading professional services firms to implement these AQ solutions, ensuring enterprises are protected and can innovate using AI and Quantum technologies. What sets SandboxAQ apart is their focus on preparing businesses and countries for the transformative effects of quantum computing on innovation, competition, and security. Their goal is to bridge the global digital divide by equipping organizations with the necessary tools and knowledge to thrive in a future influenced by quantum advancements.

Company Stage

Growth Equity (Venture Capital)

Total Funding

$583.6M

Headquarters

Palo Alto, California

Founded

2021

Growth & Insights
Headcount

6 month growth

7%

1 year growth

33%

2 year growth

158%
Simplify Jobs

Simplify's Take

What believers are saying

  • Quantum Machine Learning enhances drug discovery, aligning with SandboxAQ's focus.
  • AI-driven cryptography solutions are crucial against quantum threats, boosting SandboxAQ's offerings.
  • Defense sectors prioritize AI-powered quantum sensors, supporting SandboxAQ's AQNav technology.

What critics are saying

  • Increased competition from IBM and Google in quantum sensing technology.
  • Potential regulatory challenges in AI and quantum technologies worldwide.

What makes SandboxAQ unique

  • SandboxAQ combines AI and quantum technologies for unique enterprise solutions.
  • Their AQNav technology offers unjammable navigation, crucial for military applications.
  • Partnerships with leading institutions like Mayo Clinic enhance their healthcare solutions.

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