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Clinical & Regulatory Affairs Manager - AQMed

Remote:

Full Remote

Contract:

Full time

Salary:

183 - 257K yearly

Experience:

Expert & Leadership (>10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor's degree in biomedical engineering or related field, Minimum of 10 years in medical devices industry, Experience with FDA submissions, including 510(k), Known for launching multi-center pivotal studies, Advanced degrees preferred.

Key responsabilities:

Lead US pivotal study launch and manage feasibility studies
Develop and optimize regulatory strategies for the product lifecycle
Prepare necessary documentation for clinical research activities
Ensure compliance and submit regulatory filings to international bodies
Collaborate across teams ensuring alignment with industry standards

SandboxAQ Scaleup https://www.sandboxaq.com/

51 - 200 Employees

See more SandboxAQ offers

Job description

Ready to join the AQ era?

SandboxAQ is solving challenging problems with AI + Quantum for positive impact. We partner with global leaders in government, academia, and the private sector to identify applications that would benefit from quantum-based applications to current and future commercial challenges. We engage with customers early and throughout the development process to improve market fit.

Our team’s unique approach enables cross-pollination across a diverse range of fields, from physics, computer science, neuroscience, mathematics, cryptography, natural sciences and more! Our success comes from coalescing diverse talent to create an environment where experimental thinking and collaboration yield breakthrough AI + Quantum solutions. Join a culture where thought leadership, diverse talent, employee engagement, and technological impact will create the next tech uproar.

We are deeply committed to education as a means to advance quantum solutions and computing initiatives. We invest in future talent through internship programs, research papers, developer tools, textbooks, educational talks/events and partnerships with universities/talent hubs to attract multi-disciplinary talent. Our hope is to inspire people from all walks of life to be prepared for the quantum era and encourage a path in STEM.

About the Role

We are seeking a highly motivated and experienced Clinical & Regulatory Affairs Manager to join our AQMed team. You will play a central role in preparing for and initiating the multi-site US pivotal study, playing a key role in bringing an innovative device to market. You will also be playing a strategic and execution role in navigating the regulatory landscape for our groundbreaking medical device, CardiAQ™, and future products. This position involves developing regulatory strategies, preparing submissions, and ensuring compliance with global regulatory requirements to bring our innovative solutions to market.

What You'll Do

Clinical

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.

Regulatory

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.

About You

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.
Cool Under Pressure: You remain composed in challenging situations and act as a lighthouse amidst technical complexities.
Team Player & Builder: You contribute to a win-as-a-team culture and foster collaboration across different engineering disciplines.
Desire to Move Fast: You challenge the status quo and aim to deliver results faster than traditional timelines.
Detail-Oriented: You pay close attention to details and hold yourself and others accountable.
Passionate About Solving Unmet Medical Needs: You are deeply motivated to improve patient outcomes through innovation.
Deeply Curious: You have an insatiable desire to learn and explore new ideas.
Thoughtful About Risk: You carefully assess risks and make informed, steadfast decisions.

Preferred Qualifications

Experience with Class II and Class III cardiovascular diagnostics and imaging devices is strongly preferred.
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).

The US base salary range for this full-time position is expected to be $183k-257k per year. Our salary ranges are determined by role and level. Within the range, individual pay is determined by factors including job-related skills, experience, and relevant education or training. This role may be eligible for annual discretionary bonuses and equity.

SandboxAQ welcomes all.

We are committed to creating an inclusive culture where we have zero tolerance for discrimination. We invest in our employees' personal and professional growth. Once you work with us, you can’t go back to normalcy because great breakthroughs come from great teams and we are the best in quantum technology.

We offer competitive salaries, stock options depending on employment type, generous learning opportunities, medical/dental/vision, family planning/fertility, PTO (summer and winter breaks), financial wellness resources, 401(k) plans, and more.

Equal Employment Opportunity: All qualified applicants will receive consideration regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Accommodations: we provide reasonable accommodations for individuals with disabilities in job application procedures for open roles. If you need such an accommodation, please let a member of our Recruiting team know.