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 VP of QA/RA to join our team. The Vice President of Regulatory Affairs and Quality Assurance (VP QA/RA) will be a key member of our executive team reporting directly to the CEO, responsible for developing and executing a comprehensive regulatory, quality, and design validation strategy that aligns with the company's business objectives. This position plays a critical role in ensuring our medical monitoring products meet global regulatory requirements and quality standards. The successful candidate will provide leadership, guidance, and oversight to regulatory, clinical research, quality, and design validation teams at Sibel Health. The VP of QA/RA will also be Sibel’s primary liaison to global regulatory bodies.

WHAT YOU WILL BE WORKING ON:

• Regulatory Affairs:
• Develop and execute a regulatory strategy that ensures the timely approval and market clearance of medical devices in domestic and international markets.
• Stay informed about regulatory changes, assess their impact on our products, and adapt the company's strategy accordingly with a particular expertise in medical monitoring solutions, software as a medical device, and/or AI.
• Establish and maintain strong relationships with regulatory agencies, including the FDA and international counterparts, being the primary point of contact.
• Prepare and submit regulatory filings, including 510(k) submissions and CE mark.
• Lead interactions with regulatory agencies, including responding to inquiries, inspections, QSUBs, and audits.
• Monitor product post-market surveillance and ensure compliance with vigilance reporting requirements.
• Manage Sibel’s internal clinical research team providing guidance, leadership, and support.
• Ensure clinical research studies conducted internally and externally with partners meet all relevant standards necessary for regulatory-enabling claims.
• Quality Assurance:
• Oversee all aspects of the quality management system, ensuring that products meet or exceed quality and safety standards.
• Implement and maintain effective quality control procedures, including risk management, design controls, and product testing within Sibel’s eQMS platform.
• Manage internal and external audits, assess quality performance, and initiate corrective and preventive actions when necessary.
• Ensure compliance with relevant quality standards, including ISO 13485, FDA Quality System Regulations, and international quality requirements.
• Lead, organize, and execute audits from external entities which includes large healthcare organizations.
• Implement and maintain Sibel’s eQMS system, including document control, change control, and CAPA system.
• Establish and maintain plans, process, and protocols for product verification and validation activities that ensure product quality, reliability, and robustness that go above and beyond requirements for compliance.
• Team Leadership:
• Manage an existing team of 4 full time QARA professionals and 5 contracted verification and validation engineers.
• Recruit, develop, and mentor high-performing regulatory, quality and verification/validation teams fostering a culture of innovation, excellence, and continuous improvement.
• Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure regulatory and quality requirements are integrated into product development and commercialization processes.
  

ABOUT YOU:

• A Bachelor's degree in a relevant field
• A minimum of [10] years of experience in regulatory affairs and quality assurance within the medical device industry. Experience in either medical monitoring, medical device software, or digital health is required.
• In-depth knowledge of FDA regulations, EU regulations, ISO standards, and international regulatory requirements.
• Experience with 510(k) submissions, and interactions with regulatory agencies.
• Strong understanding of quality management systems, including ISO 13485.
• Excellent communication and interpersonal skills to effectively interact with regulatory agencies, internal stakeholders, and industry partners.
• Experience in a medical device clinical research study is a preferred qualification.
  
  

BENEFITS:

• Medical, dental, vision, life, and disability insurance.
• "Take as much time as you need" policy.
• Simple IRA plan with 3% 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.