Senior RA Specialist

A BIT ABOUT SIBEL HEALTH:

With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we’ve launched our technologies in 20 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations in the world from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

THE OPPORTUNITY:

We are looking for a Senior Regulatory Affairs Specialist to join our team. You will report to the Head of Regulatory Affairs and work with Regulatory, Clinical, and other cross-functional teams to react quickly and produce quality solutions to difficult technical challenges. Sibel’s fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative design, strong communication skills, teamwork, and more. 

This is a full-time position. The salary range for this role is $100,000 - $120,000, depending on level of experience.

WHAT YOU WILL BE WORKING ON:

• US Regulatory Strategy and Planning
• Develop and implement regulatory strategies for product development and market approval.
• Provide regulatory guidance to cross-functional teams to ensure compliance from product conception to market launch.

• US Regulatory Submissions
• Prepare and conduct pre-submissions and Q-subs
• Prepare and submit 510(k)s and other regulatory documents
• Respond to RTA and AI requests

• Determining Regulatory requirements for:
• Monitoring devices - including home use and remote patient monitoring
• Wearables and wireless technology
• Pediatric devices
• Drug Development Tools
• SaMD and AI/ML enabled devices

• Assisting with audits and inspections
• Host FDA inspections
• Regulatory SME for audits

• Regulatory Intelligence
• Keep apprised of changing regulations and the impact on Sibel’s products

• Cross-Functional Collaboration
• Support clinical efforts for regulatory clearance 
• Assist QA with creation and maintenance of documentation
• Collaborate with R&D on deliverables for regulatory submissions

ABOUT YOU:

• Bachelor’s degree in a relevant scientific or engineering discipline
• > 3 years of experience in regulatory affairs within the medical device industry
•  In-depth knowledge of US medical device regulations

YOU MAY THRIVE IN THIS ROLE IF:

• Ability to work in a fast paced environment
• Desire to gain knowledge of international medical device regulations 
• Strong project management and organizational skills
• Excellent written and verbal communication skills
• Ability to work collaboratively in a cross-functional team environment

BENEFITS:

• Medical, dental, vision, life, and disability insurance.
• "Take as much time as you need" policy.
• Simple IRA plan with employer matching.
• Company sponsored events and lunches.
• Yearly stipend for professional development.
• Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring.

Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.