Director of Regulatory Affairs

Location: Draper, UT (In office required) Job Title: Director of Regulatory Affairs Reports to: CEO Company: Xenter Inc, A TechMed Company About Us Xenter is a technology in medicine company that is bringing medical devices to the digital age. Xenter is revolutionizing medicine by developing and launching smart/wireless guidewires and catheters that transmit data through a proprietary wireless network to our proprietary cloud that collects and houses real-time Physical Intelligence medical data. Position Summary The Director of Regulatory Affairs will lead Xenter’s global regulatory strategy, submissions, and agency interactions. This role is both strategic and operational—responsible for developing regulatory pathways for innovative products, building scalable regulatory infrastructure, and partnering cross-functionally to drive successful product approvals and launches. This leader will play a key role in preparing the organization for public company expectations, ensuring regulatory processes are robust, audit-ready, and aligned with commercialization timelines. Key Responsibilities Regulatory Strategy & Execution Develop and execute global regulatory strategies for Class II devices Lead preparation and submission of 510(k), IDE, and international filings. Serve as primary liaison with regulatory authorities Provide regulatory guidance for product development, clinical studies, labeling, and claims. Anticipate regulatory risks and proactively develop mitigation strategies. Cross-Functional Leadership Partner with R&D, Clinical, Quality, Manufacturing, and Commercial teams to align regulatory requirements with product development and launch timelines. Ensure regulatory input into design controls, risk management, and verification/validation activities. Quality & Compliance Alignment Collaborate with Quality leadership to ensure alignment with QMS requirements (21 CFR Part 820 / ISO 13485). Support internal and external audits and regulatory inspections. Ensure documentation and processes meet public company governance expectations. IPO & Corporate Readiness Contribute to due diligence activities for investors and board reporting. Build scalable regulatory infrastructure appropriate for a pre-IPO organization. Develop KPIs and reporting metrics for executive leadership and the Board. Team Development Build, mentor, and scale the Regulatory Affairs function. Establish external consultant and partner relationships as needed. Qualifications Required: Bachelor’s degree in life sciences, engineering, or related field (advanced degree preferred). 10+ years of regulatory affairs experience in medical devices. Demonstrated experience leading U.S. regulatory submissions (510(k), PMA, De Novo). Experience interacting directly with the U.S. Food and Drug Administration. Proven track record supporting product commercialization. Strong leadership and cross-functional collaboration skills. Preferred: Experience in a venture-backed or pre-IPO environment. Global regulatory experience Experience with innovative or novel device technologies. #J-18808-Ljbffr