AI Regulatory Submissions Director (Remote)
AI Regulatory Submissions Director (Remote)
*This is an unpaid, time flexible, remote role position*
Description
Life Singularity offers a breakthrough predictive health platform delivering personalized, geospatial monitoring with a strong focus on “prospective” virtual care for prevention of health events. The Life Singularity virtual health assistant combines empathy with innovative avatar-based technology, advanced sensing of emotions, behaviors and lifestyles, and Artificial Intelligence (AI) that generates actionable, real-time data and intelligent analytics, enabling clinicians to make better, timelier and “predictive” care decisions, catching the disease ahead of time.
Here, at Life Singularity, chasing your passion will no longer be a side goal, but rather, our number one priority.
As a potential applicant, you may be confused as to why applying for an unpaid internship can be beneficial. While Life Singularity may be a small start-up, we hope to make your internship as valuable as possible. We want to utilize your skills to build advanced systems and help grow not only our company, but your portfolio. For many interns at Life Singularity, this sole experience has benefited them in the job market as we are an extremely well-connected company that is continuing to redefine the AI/Medical sector.
*We are very flexible at Life Singularity - We can work together to figure out which days/hours/schedule works best for you*
Preferred Skills
- Create and execute regulatory strategies and plans for assigned products in the domestic and international markets
- Support and provide regulatory expertise to assigned product development projects
- Maintain expertise in the interpretation of domestic and international regulations and laws as they apply to the licensing, registration, manufacturing, shipping, and selling of assigned products
- Prepare and submit 510(k)’s, registration and listing, and other product submissions according to FDA guidelines as well as any required reporting
- Review and approve product labeling plans, labeling, and marketing communications, and assure claims are substantiated
- A bonus if you have experience with IDE’s
Qualifications
- BA/Master’s or equivalent in engineering, life sciences, or other similar technical field
- Regulatory certificate or RAC preferred
- Minimum of 2-3 years within medical device industry
- Excellent knowledge of FDA requirements, with experience supporting regulatory submissions and technical files
- Experience with clearance of medical devices outside of the US preferred
The interns will be required to work 20 hours per week on a flexible schedule during Fall and Spring Semesters and 40 hours per week during summer. Individual exceptions for less than 20 hours (for example, for PhD interns) can be discussed on a case-by-case basis. The interns will be reporting to a senior resource with multiple years of experience in their requisite domains of AI, Data Science, Social Determinants, Regulatory standards, Epidemiology, Data Standardization, Visualization, NLP, Human-Centered Design, AR/VR and Quantum technologies.