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Regulatory Affairs Intern
San Francisco Part-time and Full-time
The Regulatory Affairs intern will support regulatory activities for software as a medical device to develop submissions while interpreting global regulations.
Activities include:
- Assist in the compilation of requirements for global regulatory submissions (510k, de novo, technical document) of software as a medical device
- Support the acquisition and management of files to meet applicable regulations (design control/design history files, risk management files, usability files)
- Attend project team meetings with RA lead to assist in strategic discussions to hone team collaboration skillset
- Learn regulatory affairs competencies to ensure product registration lifecycle processes compliance
- Evaluate current processes and propose opportunities for efficiencies/improvements
- Data analytics specifically from software applications and write ups
Candidate Requirements:
- US and Global Regulatory Policies Understanding and Shaping activities
- Currently enrolled full-time in an undergraduate program, or enrolled full-time in a graduate program (M.S., M.E., Ph. D., or M.D.), pursuing a degree majoring in a scientific, technology, engineering, business, or law related field
- Examples include, biomedical, mechanical, electrical engineering, data analytics/applied statistics, quantitative modeling in biology, pharmacy, life Sciences, medical / scientific writing or public health administration
- Candidate must be legally authorized to work in the United States and not require sponsorship for employment visa status (e.g., H1-B status) now or in the future
- Candidates need to be proficient with Microsoft Office, Word, Excel (including a high proficiency with generating pivot tables and graphs), and Power Point, and have strong oral and written communication skills
- Able to work individually, as well as, part of a group, with curiosity and flexibility
- Possess a “can do” approach, and courage to speak your voice and suggest innovative ideas
Why you should join SafeBeat Rx
At SafeBeat Rx (YC S21), we are building ECG software that powers Cardiac Therapeutics – All from your Phone. Our take-home solution helps patients to get care at home, by combining FDA-cleared wearables with our ECG software that catches hearth rhythm changes very quickly to allow for clinical decision making. By joining our team, you will have a direct impact on millions of patients’ lives.
If our mission and product excite you, we would love to connect.