Head of Quality & Regulatory Affairs, Endovascular Robotics

Siemens Healthineers

4d•Onsite

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. This is a role well suited to an ambitious and experienced professional, looking for the next step in your career. As Head of Endovascular Robotics (EVR) Quality & Regulatory Affairs, you will be responsible for overseeing all quality and regulatory affairs activities for EVR. In this role, you will: Own the Endovascular Robotics Regulatory Affairs strategy and operational implementation, overseeing all regulatory pathways across key markets (US, EU, etc) and leading the Quality organization ensuring compliance with all applicable regulations. Develop and execute the EVR Quality & Regulatory Affairs strategy supporting new product development, market access, product lifecycle, and long-term business growth. Develop and execute regulatory strategies for clinical-stage and future commercial product in 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 Regulatory in 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, including Q-submissions, IDE application, and regulatory packet for Ethics Committee/IRB submission. Lead the preparation, approval, and maintenance of regulatory submissions, including technical documentation, CE marking, FDA Premarket Submission, NMPA Green and other international registrations Provide strategic 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, and inspection readiness. Partner with R&D and commercial teams to assess regulatory feasibility, safety, scientific credibility, and differentiation early in development. Provide clear regulatory and scientific guardrails 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, and cross-functional collaboration. Monitor the regulatory developments and enforcement trends; assess risk and proactively advise on impact and mitigation. Collaboration cross-functionally to align regulatory and quality priorities with business and clinical goals. Experience in QA oversight and management of products through the lifecycle of medical device product development. Experience with applying regulatory requirements including CFR, ISO, GMP, and EU MDR.

Requirements

Bachelor’s or Master’s Degree in a scientific discipline.
15+ years of successful experience leading quality & regulatory affairs teams in large, matrixed multi-national organizations with at least 5 years of supervisory/management experience.
Previous regulatory submissions experience with complex electromechanical, software controlled robotic systems.
Extensive experience interacting with US and international regulatory agencies.
Strategic, enterprise minded decision maker with the ability to connect regulatory and quality decisions to broader business impact and long-term organizational objectives.
Expert level knowledge of quality and regulatory affairs in a global environment.
Outstanding written and verbal communication skills.
Strong presentation skills
Ability to collaborate with diverse groups of professionals
Comfortable interacting with C-Level Executives, healthcare professionals, and regulatory agencies
Ability to work independently and within a large team
Ability to think strategically
Experience developing products under QMSR (formerly QSR, 21 CFR 820) and ISO 13485.
Successful track record of drafting, writing, and submitting regulatory documents and ensuring compliance related to manufacturing standards, clinical trials, submission data, etc.
FDA audit experience with successful outcomes.
Experience with FDA, NMPA and notified bodies for CE Mark (MDR).
In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US Class II and III devices, EU CE Mark (and China Green pathway – preferred) with a demonstrated record of success in gaining regulatory approval.
Ability and willingness to work in a lean, fast paced environment.
A desire to learn, ask questions and be resourceful to identify innovative applications, develop own, creative solutions and solve complex problems

Nice To Haves

Experience in Neuro devices, SaMD and/or advanced imaging systems preferred.
Experience with the NMPA Green Channel ("Special Examination Procedures for Innovative Medical Devices"), preferred.
RAC-devices certificate preferred.
Additional international/global regulatory experience preferred.

Responsibilities

Own the Endovascular Robotics Regulatory Affairs strategy and operational implementation, overseeing all regulatory pathways across key markets (US, EU, etc) and leading the Quality organization ensuring compliance with all applicable regulations.
Develop and execute the EVR Quality & Regulatory Affairs strategy supporting new product development, market access, product lifecycle, and long-term business growth.
Develop and execute regulatory strategies for clinical-stage and future commercial product in 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 Regulatory in 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, including Q-submissions, IDE application, and regulatory packet for Ethics Committee/IRB submission.
Lead the preparation, approval, and maintenance of regulatory submissions, including technical documentation, CE marking, FDA Premarket Submission, NMPA Green and other international registrations
Provide strategic 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, and inspection readiness.
Partner with R&D and commercial teams to assess regulatory feasibility, safety, scientific credibility, and differentiation early in development.
Provide clear regulatory and scientific guardrails 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, and cross-functional collaboration.
Monitor the regulatory developments and enforcement trends; assess risk and proactively advise on impact and mitigation.
Collaboration cross-functionally to align regulatory and quality priorities with business and clinical goals.
Experience in QA oversight and management of products through the lifecycle of medical device product development.
Experience with applying regulatory requirements including CFR, ISO, GMP, and EU MDR.