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About the company:

Our client is a world leader in applying deep learning to medical image acquisition to enable faster, safer and smarter medical imaging. They deliver responsible AI solutions that measurably improve radiology workflows and patient experience, with a vision that every person has access to timely diagnosis, highquality care and a longer, healthier life. They have multiple FDAcleared and CEmarked AI software products in routine clinical use across hundreds of hospitals and imaging centers worldwide, backed by a robust multimodality pipeline and strong investment in R&D. The team includes leading radiologists, scientists and engineers from top universities, many from major imaging OEMs, and the company has been repeatedly recognized as a top global AI and digital health company. They operate as an equal opportunity employer.

About the role:

The Head of Quality Engineering & Regulatory Affairs (Head of QERA) is a key executive reporting to the Chief Product Officer, responsible for building, leading and maintaining the company’s Quality and Regulatory Affairs functions and systems. The role owns the quality and regulatory strategy that enables global commercialization of AI/ML SaMD products and serves as both Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC). This position can be remote in the US or hybrid in the San Francisco Bay Area, includes up to 30% travel for audits and leadership meetings, and offers H1B sponsorship.

Key Responsibilities:

• Lead the development, implementation, maintenance and continuous improvement of the company’s quality and regulatory programs and strategies.
• Define quality standards and objectives, embed quality into product development and deployment processes, and oversee vendor/supplier quality.
• Develop and execute a global regulatory compliance strategy aligned with business and commercialization goals for AI/ML SaMD.
• Own and support QMS processes, ensuring regulated systems and documentation are inspectionready at all times.
• Partner with R&D, Product, Engineering and Marketing to enable timely global market access and lifecycle management of products.
• Plan and oversee internal and external audits and regulatory inspections, including followup and effectiveness of CAPAs.
• Maintain and improve departmental policies and procedures (including training, CAPAs, ECRs, ECNs) and drive timely closure.
• Build and develop the QERA organization, including people, processes and tools, to meet near and longterm objectives.
• Ensure Quality System compliance with FDA 21 CFR Part 820, EU MDR and other relevant global regulations and standards.
• Act as MR and PRRC and support data protection activities such as audits, investigations and training across PHI, customer, HR, financial and proprietary data.
• Provide executivelevel reporting on quality and regulatory performance, risks and mitigation plans.

Key requirements:

• Bachelor’s degree in a scientific, engineering or related discipline required; Master’s degree a plus.
• Senior leadership experience in QA/RA within medical devices, SaMD or related regulated healthcare domains.
• Demonstrated experience hosting regulatory inspections and interacting with regulators/notified bodies.
• Handson experience with CSV and implementation of QMS and ERP software (requirements, specifications, workflows, validation, IQ/OQ/PQ).
• Solid understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, healthcare compliance and regulations for clinical research and medical devices.
• Proficiency with ISO 13485, GCP, QSIT and relevant CFR parts (including 210, 211 and 820), plus ISO 14971, IEC 62304 and IEC 62366.
• Strong track record of successful global registrations and market access.
• Proven ability to build a culture of accountability, ownership and continuous improvement and to work effectively in a matrixed, crossfunctional environment.
• Excellent written and verbal communication skills, strong analytical and problemsolving capabilities, and high independence with strong team integration.