Head of Quality & Regulatory Affairs, Endovascular Robotics

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. Required skills to have for the success of this role 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. Experience in Neuro devices, SaMD and/or advanced imaging systems preferred. Extensive experience interacting with US and international regulatory agencies. Experience with the NMPA Green Channel ("Special Examination Procedures for Innovative Medical Devices"), preferred. 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. RAC-devices certificate preferred. Experience with FDA, NMPA and notified bodies for CE Mark (MDR). Additional international/global regulatory experience preferred. 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 Travel up to 25%, including short term international trips Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. The base pay range for this position is: $238,300

• $327,657 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement:

Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the

Law:

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

Reasonable Accommodations:

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you're unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

California Privacy Notice:

California residents have the right to receive additional notices about their personal information. To learn more, click here.

Export Control:

"A successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."

Data Privacy:

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

To all recruitment agencies:

Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. Head of Quality & Regulatory Affairs, Endovascular Robotics (part of Siemens) 3.8 3.8 out of 5 stars Newton, MA 02466 $238,300

• $327,657 a year
• Full-time Siemens Healthineers 520 reviews $238,300
• $327,657 a year
• Full-time 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. Required skills to have for the success of this role 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. Experience in Neuro devices, SaMD and/or advanced imaging systems preferred. Extensive experience interacting with US and international regulatory agencies. Experience with the NMPA Green Channel ("Special Examination Procedures for Innovative Medical Devices"), preferred. 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. RAC-devices certificate preferred. Experience with FDA, NMPA and notified bodies for CE Mark (MDR). Additional international/global regulatory experience preferred. 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 Travel up to 25%, including short term international trips Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. The base pay range for this position is: $238,300

• $327,657 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement:

Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the

Law:

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

Reasonable Accommodations:

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you're unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

California Privacy Notice:

California residents have the right to receive additional notices about their personal information. To learn more, click here.

Export Control:

"A successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."

Data Privacy:

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

To all recruitment agencies:

Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.