Director of Quality Assurance and Regulatory Affairs

Provect AI is a well-funded medical imaging company bringing advanced 3D imaging to the operating room through its FDA-cleared, vendor-agnostic platform. Using a physics-aware AI approach, Provect transforms standard C-arm X-rays into volumetric 3D images, helping surgeons visualize anatomy with greater confidence and making advanced imaging more accessible in hospitals and ambulatory surgery centers. Founded by experienced MedTech entrepreneurs with multiple FDA-cleared products and successful exits, Provect collaborates with clinicians from leading health systems and academic medical centers. With support from more than 30 clinical opinion leaders and 25 validation studies, Provect is entering its next phase of clinical adoption and growth, focusing on spine surgery, interventional pain, and orthopedics. Join a collaborative, fast-moving team to bring new imaging capabilities into everyday surgical care. Director of Quality Assurance and Regulatory Affairs - Provect AI The Director of Quality Assurance and Regulatory Affairs will lead the company’s Quality and Regulatory functions, ensure compliance with FDA regulations, and lead subsequent FDA 510(k) submissions. The ideal candidate will bring deep experience in medical device production, operations, strong technical expertise, and the ability to establish and scale processes in a fast-paced environment. Quality Assurance Leadership oDevelop, implement, and oversee the company’s Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, and other relevant standards. oLead quality processes, including design control, risk management, and CAPA systems. oDrive a culture of quality across all aspects of the organization. Regulatory Affairs oDevelop and execute regulatory strategies for FDA 510(k) submissions, working collaboratively with internal teams and external consultants. oEnsure compliance with applicable medical device regulations throughout product development and commercialization. Cross-Functional Collaboration oPartner with R&D, Operations, and Product Development teams to align quality and regulatory objectives with business goals. oWork closely with the CTO to support product development efforts in mechanical and electronic engineering. oAssist in scaling the organization’s documentation processes and ensuring robust verification and validation practices. Qualifications Experience oMinimum of 8 years of Quality Assurance and Regulatory Affairs experience in Medical Devices, including leadership roles. oMinimum of 5 years of experience in operations, R&D, or industrial engineering in Medical Devices. oProven experience with FDA 510(k) submissions and regulatory pathways. Technical Expertise oHands-on product verification and validation activities. oPractical Mechanical, Electrical, or Software Engineering knowledge. oRegulatory compliance for medical devices, including software, hardware, and disposables. Skills oAbility to build, manage, and mentor high-performing teams. oExcellent documentation skills with a detail-oriented approach. oStrong communication skills to work effectively with internal teams and regulatory bodies. What We Offer o Opportunity to join a high-impact MedTech startup at a pivotal stage of growth. o Equity/stock options to share in the company’s success. o Collaborative, innovative culture with a focus on quality and excellence. #J-18808-Ljbffr Provect AI