Regulatory Affairs Interns

SafeBeat Rx; United States; On-site; USD 20,000 - 30,000; Full time

Job summary

SafeBeat Rx in the United States is looking for a Regulatory Affairs intern to support regulatory activities for software as a medical device. The intern will assist in the compilation of requirements for global regulatory submissions and support file management to meet applicable regulations.

If you are enrolled in a relevant undergraduate or graduate program and want to make a direct impact on patients' lives, we would love to connect with you!

Qualifications

• Enrollment in a scientific, technology, engineering, business, or law-related program.
• Proficient with generating pivot tables and graphs in Excel.
• Ability to work individually and as part of a group.

Responsibilities

• Assist in regulatory submissions for software as a medical device.
• Support file management to meet applicable regulations.
• Participate in project team meetings for strategic discussions.

Skills

US and Global Regulatory Policies Understanding

Microsoft Office

Oral and written communication

Education

Currently enrolled in an undergraduate or graduate program in related fields

Job description

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.