Head of Clinical and Regulatory Affairs at Siemens Medical Solutions USA, Inc. in Newton, Massachusetts

Job Description:

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.


We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Head of Clinical, Regulatory, and Quality to take on the role of strategic regulatory lead while ensuring quality system requirements are continuously improved. In this leadership role, you will have the opportunity to develop new approaches for achieving and defining business objectives while working with other teams around the globe.


Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.


Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers .


This is a role well suited to an ambitious professional, looking for the next step in their career. As the Head of Clinical and Regulatory Affairs , you will be responsible for:


• Represent the Clinical and Regulatory functions at the leadership team level.


• Lead activities associated with regulatory approval of a novel robotic medical device in the US market and supporting international markets.


• Have a strong ownership of regulatory processes and ensuring continuity with Siemens Healthineers global standards and processes.


• Oversee the Clinical Affairs team with a focus on ensuring operational excellence.


• In collaboration with subject matter experts, write, prepare, edit, and review FDA submissions; documents including, but not limited to:


o Significant Regulatory Risk Assessments


o Pre-Submissions and IDE Applications


o Pre-market applications (510(k), de novo, PMA)


o CER documents


• Develop RA strategies, support and manage interactions with regulatory agencies including responses to regulatory submissions.


• Review validation protocols and reports for regulatory submission soundness including clinical and technical protocols and reports and/or other device documentation.


• Support change control activities that require regulatory agency approval per US regulatory requirements.


• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.


• Ensure compliance with regulatory agencies and all applicable standards worldwide.


• Regularly interact with company executives, leaders, and customers to collaborate and formulate plans to achieve desired outcomes.


• Work on complex challenges that require in depth knowledge of regulatory principles and practices.


• Oversee and ensure proper staffing and support the development of the teams.


• Manage direct staff and personal involvement with broad cross functional teams to deliver high quality strategies in a compliant and efficient manner.


• Other duties as assigned.



Required skills to have for the success of this role:


• Bachelor's degree in a scientific discipline required, Master's degree or higher preferred.


• Minimum of 1 0+ years' experience in strategic Regulatory Affairs with knowledge of Clinical trial management.


• Minimum of 5-7 years' management experience with strong communication skills.


• Previous regulatory submissions experience with complex electromechanical, software controlled robotic systems. Experience in Neuro devices, SaMD and/or advanced imaging systems preferred.


• Experience developing products under QSR, 21 CFR 820, 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 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, and EU CE Mark with a demonstrated record of success in gaining regulatory approval.


• Ability and willingness to work in a lean, fast paced environment.


• Willing to travel up to 10%.


At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.



If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers .


If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about .


As an equal-opportunity employer we are happy to consider applications from individuals with disabilities



Equal Employment Opportunity Statement

Siemens 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.


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