Quality Assurance & Regulatory Affairs Intern

Infinite Biomedical Technologies (IBT) is at the forefront of helping people achieve intuitive operation of their prosthetic arms. We are bridging the gap the between man and machine through the development of non-invasive electrode interfaces, flexible batteries, and stylish yet simple software applications to operate prosthetic arms. To date, our devices have impacted over 5000 people in 37 countries across the world. 

We are looking for a QA/RA Intern to create and manage documentation for quality system updates and 

global regulatory submissions. 

You Will: 

• Perform updates to a GMP Compliant, ISO 13485 compliant Quality Management System 

• Create, manage and update regulatory documentation to be compliant with EU regulations 

• Participate in post market surveillance activities and identify updates to risk management 

• Conduct literature and-state-of-the-art reviews to support clinical evaluation reports for CE Mark 

• Participate in complaint handling 

Qualifications: 

• Undergraduate student with basic experience in medical devices 

• Experience in producing high quality technical documentation 

• Strong written, verbal and interpersonal skills 

• Demonstrated excellence in ability to organize oneself and attention to detail 

• Must be able to meet stringent deadlines 

• Must be willing to commute to our office in downtown Baltimore, Maryland intermittently 

Nice to Haves: 

• Prior quality and regulatory experience 

• Familiarity with 

o ISO 14971 risk management 

o Technical file for CE Marking 

What’s in it for you: 

• Work closely with cutting edge technology: such as multi-articulated prosthetic hands, advanced algorithms, and small form factor/low energy components.  

• Gain experience in regulatory activities for medical devices: You will gain first hand experience in creation of documentation for getting approvals from global regulatory bodies as well as for maintaining compliance.  

• Work in a close-knit, startup environment: We strive to create an intellectually stimulating and collegial working environment. We follow the philosophy of “work hard, play hard”: we have regular movie nights, ping pong tournaments, plan field trips, play touch football, play music, and generally have a good time.  

• Compensation: Stipend of $15 - $20/hour. Looking for commitment of 10-15 hours/week for 3-6 months. 

Still Interested? To apply, please send send a PDF resume and any relevant information (images, videos) via email to careers@i-biomed.com. More info can be found at www.i-biomed.com.