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 are transforming the healthcare ecosystem with 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. The company has several FDAcleared and CEmarked AI software products used in over 900 hospitals and imaging centers worldwide, a robust multimodality portfolio and strong investment in R&D. The team includes leading radiologists, scientists and engineers from top universities (such as Stanford, Harvard and MIT) and major imaging OEMs, and the company has been repeatedly recognized as a top global AI and digital health company. They are an equal opportunity employer.

About the role:

The Quality Engineering & Regulatory Affairs Manager will be part of the executive team with primary responsibility for building and maintaining the Quality System and leading quality and regulatory programs. This role is strategically critical for achieving commercialization goals, ensuring continuous improvement and that highquality AI/ML SaMD products reach emerging, regulated and clinical markets globally. The position also serves as Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC), working crossfunctionally to align quality and regulatory strategies with overall business objectives.

Key Responsibilities:

• Lead the development, implementation, maintenance and overall success of quality and regulatory programs and strategies.

• Define quality standards and objectives, embed quality into product development and any manufacturing/deployment processes, and oversee vendor relationships and quality standards.

• Develop, implement and support a comprehensive global regulatory compliance strategy aligned with company business and commercialization goals.

• Support and participate in QMS processes for AI/ML SaMD products, ensuring systems and documentation are always inspectionready.

• Partner proactively with R&D, Marketing and other functions to provide regulatory guidance for global market access.

• Participate in data protection activities (audits, investigations, training) and ensure compliance with applicable policies and procedures.

• Plan and oversee internal and external audits, including followup and CAPA effectiveness.

• Review, edit and maintain departmental policies and procedures, including training, CAPAs, ECRs and ECNs.

• Develop employees, processes and technology within QERA to meet annual and longterm objectives.

• Review and interpret regulatory requirements and implement Quality System policies and procedures to ensure compliance with FDA 21 CFR Part 820 and EU requirements.

• Act as MR and PRRC for the company.

Key requirements:

• Bachelor’s degree in a science, engineering or related discipline required; Master’s degree is a plus.

• Strong understanding of global registration requirements and a demonstrated track record of successful market access.

• Experience hosting regulatory inspections and interacting with regulators/notified bodies.

• Experience with CSV and implementation of QMS and ERP software (requirements, specifications, workflow documentation, validation script writing, IQ/OQ/PQ execution).

• General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, healthcare compliance and regulations/standards for clinical research and medical devices.

• Proficiency with ISO 13485, GCP, QSIT and applicable CFR parts (including 210 and 211), plus working knowledge of ISO 14971, IEC 62304 and IEC 62366.

• Proven ability to build a culture of accountability and ownership and to establish and maintain strong internal and external partnerships.

• Able to work effectively at all levels in a matrix organization, with excellent written and verbal communication skills.

• Strong analytical and problemsolving skills, able to manage shifting priorities, multiple projects and demanding timelines.

• Highly independent, selfmotivated and able to integrate effectively within crossfunctional teams.