The Director of Clinical, Quality, and Regulatory Affairs (CQRA) is responsible for leading all CQRA activities within the MedTechAI division. This role ensures that customer solutions engineered by the division comply with applicable regulatory requirements, global quality system standards, and clinical evidence expectations.
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The Director of CQRA plays a central role not only in overseeing internal compliance but also
in supporting and driving regulatory submissions for customer programs in major markets, particularly Europe (EU MDR) and the United States (FDA).
The Director ensures that regulatory, clinical, and quality considerations are embedded across development activities and that the Quality Management System (QMS) is robust, efficient, and tailored to MedTechAI's model.
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* Lead the Clinical, Quality, and Regulatory Affairs function.
* Establish governance, processes, and standards aligned with the operating model and customer program requirements.
* Ensure that all engineered solutions meet applicable regulatory, clinical, and quality standards.
* Maintain and continuously improve the Quality Management System in accordance with ISO 13485 and other relevant standards.
Regulatory Affairs Strategy & Execution
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* Define and execute regulatory strategies for customer product developments across EU MDR and FDA pathways.
* Prepare, coordinate, or support regulatory submissions on behalf of customers, including technical documentation, 510(k), De Novo, and other applicable pathways.
* Serve as a regulatory interface for customer RA teams and, where required, with notified bodies and competent authorities.
* Translate regulatory expectations into clear requirements for engineering, program management, and clinical activities.
* Oversee regulatory impact assessments related to hardware, SaMD, AI-enabled technologies, and medical electrical equipment.
Quality Assurance & Design Control
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* Ensure the application of design control, risk management, verification, validation, and change management processes across all programs.
* Oversee quality deliverables, including documentation, traceability matrices, risk assessments, and compliance evidence.
* Support supplier qualification and oversight activities, ensuring that external partners meet the necessary quality standards.
* Coordinate handling of nonconformities, CAPA, and quality investigations related to deliverables.
* Lead preparation and readiness for customer audits and external assessments.
Clinical Affairs Support
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* Contribute to clinical strategy planning and ensure alignment with regulatory pathways and product claims.
* Oversee integration of clinical evidence, usability data, and risk-benefit analyses into product documentation.
* Support clinical study planning, protocol review, and data assessment where applicable.
* Oversee interactions with Clinical Research Organizations (CROs), defining expectations, reviewing deliverables, and ensuring proper execution of clinical studies conducted on behalf of customers.
Cross-Functional Collaboration
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* Partner with Product Engineering to ensure regulatory and quality considerations shape program decisions from the earliest stages.
* Provide CQRA input to customer proposals, statements of work, program feasibility assessments, and contractual obligations.
* Maintain consistent communication with customer teams on regulatory and quality expectations, responsibilities, and timelines.
* Support internal leadership by providing clear and accurate CQRA status updates, risk assessments, and recommendations.
Operational and Team Leadership
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* Build efficient CQRA processes that scale with organizational growth and an evolving portfolio.
* Lead, mentor, and develop CQRA staff, and contribute to training initiatives across the organization.
* Promote a culture of quality, compliance, transparency, and continuous improvement.
Qualifications
Required
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* Bachelor’s or Master’s degree in Engineering, Life Sciences, Biomedical Engineering, or a related field.
* 7 to 10 years of experience in Regulatory Affairs, Quality Assurance, or Clinical Affairs within the medical device or regulated health-tech environment.
* Strong knowledge of EU MDR, FDA regulatory pathways, and technical documentation requirements.
* Experience with regulatory submissions including 510(k), De Novo, and EU technical files.
* Strong understanding of ISO 13485, design control, risk management (ISO 14971), validation principles, and clinical study requirements, including Good Clinical Practice (ICH GCP) and associated documentation standards.
* Experience with regulated software, including SaMD and AI-enabled solutions.
* Excellent communication and collaboration skills across internal and customer-facing teams.
Preferred
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* Experience working in customer solutions, contract engineering, or collaborative development environments.
* Experience with medical electrical equipment (IEC 60601 series), cybersecurity, and data protection requirements for connected devices.
* Experience managing audits, inspections, or interactions with notified bodies.
* Strong ability to balance regulatory rigor with practical program execution. xjrgpwk
* Occasional travel up to 20–30% for audits, customer engagements, regulatory interactions, and cross-site collaboration.
Equal Opportunity Statement
We support equal opportunities, without any discrimination; The research complies with Legislative Decree 198/2006
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