Regulatory Affairs Intern

Durham, NC 27709
Full-time
Salary: $15.00 to $18.00 /hour


Baebies – guided by the vision that “everyone deserves a healthy start” – develops and commercializes products and services that enable early disease detection and comprehensive diagnosis for all. Baebies’ products include SEEKER®, an FDA-authorized and CE-marked high throughput newborn screening platform, and FINDER®, a CE-marked low-volume testing platform that is currently not commercially available in the U.S. Our mission is to save lives and make lives better for all by bringing new technologies, new tests and new hope to children, parents and healthcare professionals worldwide.

Job Purpose

We are looking for a regulatory affairs intern to assist with transitioning our quality system and documentation required for compliance with the new European Union In-Vitro Diagnostic Regulation (EU IVDR 2017/746).

Responsibilities

· Reading and interpreting regulatory requirements from the new EU IVD Regulation

· Writing and revising new and existing procedures to comply with the EU IVD Regulation

· Assisting in the creation and review of technical files required for CE-marking and EU submissions

· Other regulatory assistance as assigned

Qualifications

Qualifications and attributes for a successful internship include:

· Rising college junior/senior or recent graduate preparing to enter graduate school. Major in science related field preferred.

· Interested in learning about the medical device market, in vitro diagnostic devices, U.S. and global regulatory requirements for marketing medical devices

· Experience with Microsoft Office

· Excellent verbal and written communication skills

· Self-starter, sense of urgency

· Strong work ethic

· Critical thinker

· Attention to detail; organized

· Able to work independently and within a team

· Able to work remotely and meet work expectations

· Able to devote 40 hrs of work per week

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