Business Unit: Digital Services
Requisition Number: 244950
Primary Location: United States-New Jersey-Princeton
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Master's Degree
Travel Required: 5%
Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as Regulatory Affairs Professional specializing in AI solutions for Healthcare
Provides Regulatory Affairs expertise for the Siemens Healthineers, Digital Technology & Innovation (DTI) division of Siemens Medical Solutions USA, Inc. in Princeton, NJ. The successful candidate must demonstrate excellent domain knowledge, strong teamwork skills, resourcefulness, and the ability to work effectively within a matrixed organization. This position is based in Princeton, NJ, and includes communication and interaction with several Siemens Healthineers business units.
- Develops regulatory approval approaches for complex, technical problems related to Artificial Intelligence (AI) / Machine Learning (ML) based software as a Medical Device (SaMD).
- Plans and prepares product (software component) related submissions with Siemens internal or external organizations according to regulatory requirements.
- Submits required documentation/information to local authorities (FDA) and/or Siemens internal stakeholders.
- Identifies, analyzes and implements country specific requirements necessary for product (software component) related submissions.
- Supports various types of (clinical) studies to gain insights for product development and/or to gather/evaluate data in submission activities.
- Creates and reviews procedures, policies and guidelines as needed for maintaining regulatory compliance, including maintaining adequate documentation for audits/inspections.
- Maintains current knowledge of relevant regulations (e.g. FDA regulations, ISO 13485, MDR, etc.).
- Acts as liaison between Regulatory Affairs and other departments within the Company in support of International Registration and approval.
- Performs review of promotional material for regulatory compliance according to country specific requirements.
- Performs training within the organization regarding country specific regulatory requirements, when applicable.
- Provides functional advice and guidance to colleagues and customers.
Required Knowledge/Skills, Education, and Experience
- BS/BA in a related discipline, or equivalent combination of education and experience.
- 5+ years of (hands on) experience in Regulatory Affairs with FDA regulated products, including successful demonstration of key responsibilities and knowledge as presented above.
- Previous experience with 510(k), IDE, and/or PMA submissions.
- Excellent interpersonal and communication (verbal & written) skills, and the ability to collaborate effectively with others.
- Solid professional judgment and problem-solving competence.
Preferred Knowledge/Skills, Education, and Experience
- The ideal candidate should be “hands-on”, and proactive in working with regulatory agencies and internal Siemens stakeholders, providing expertise and guidance to ensure that all relevant requirements are met.
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.