Head of Quality & Regulatory Affairs, Endovascular Robotics

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This is a role well suited to an ambitiousand experiencedprofessional, looking for the next step in your career.AsHead of Endovascular Robotics(EVR) Quality & Regulatory Affairs,you willbe responsible foroverseeing all quality and regulatory affairsactivitiesfor EVR.In this role, you will:


* Own theEndovascular Robotics Regulatory Affairs strategyand operational implementation, overseeingall regulatory pathways across key markets (US, EU,etc)and leadingthe Quality organization ensuring compliance with all applicable regulations.



* Develop and execute the EVR Quality & Regulatory Affairs strategy supportingnew product development,market access, product lifecycle, and long-term business growth.



* Develop and execute regulatory strategies for clinical-stage and future commercialproductin the US, EU, and other global markets.



* Serve as a liaison with regulatory bodies, including the FDA, and manage all compliance-related interactions.


* Act as the PRRC (person responsible for regulatory compliance) for the organization.



* Develop and implement robust quality assurance programs, policies, and processes to ensure product performance and customer satisfaction.



* Represent Quality and Regulatoryin strategic business decisions, including clinical study design and regulatory approvals.



* Drive global regulatory strategies for new product submissions, pre-market notifications, and lifecycle management.



* Lead the preparation and approval of clinical-stage activities, includingQ-submissions,IDE application, andregulatory packet for Ethics Committee/IRB submission.



* Lead the preparation, approval, and maintenance of regulatory submissions, including technical documentation,CE marking,FDA Premarket Submission,NMPA Greenand other international registrations



* Providestrategic guidance to the leadership team, R&D, operations, and commercial teams.



* Drive strong collaboration and coordination across internal stakeholders.



* Oversee internal and external audit programs, supplier quality manager, CAPA effectiveness, andinspectionreadiness.



* Partner with R&D and commercial teams to assess regulatory feasibility, safety, scientificcredibility, and differentiation early in development.



* Provide clear regulatoryand scientificguardrails to accelerate innovation while avoiding late-stage surprises.



* Support stage-gate decision making with risk-based regulatory and evidence assessments.



* Develop high-performing Quality & Regulatory Affairs teams, promoting a culture of accountability, quality...