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 a Regulatory Affairs Professional
This is a role well suited to an ambitious
professional, looking for the next step in their career. As a Regulatory Affairs Professional, you will be responsible for:
- As a member of a multi-discipline project team, you will develop and execute regulatory strategies for assigned projects to enable successful registration of IVDs in U.S., EU, Japan and worldwide.
- You will prepare U.S., EU regulatory submissions for in vitro diagnostic products.
- You will collaborate with country RA organizations to successfully register products in JP, Canada, China and rest of the world.
- You will review and approve product labeling, advertising/promotional material, verification plans and reports.
- You will maintain awareness of U.S. and global regulatory requirements and assess their impact to the business.
This position may suit you best if you are familiar
with what is below, and would like to develop your career with
- You are able to multi-task and work effectively in a dynamic environment.
- You have experience on project teams representing RA and bringing new products to market.
- You have strong PC skills (MS Office applications, Adobe, Outlook, OneNote, SAP)
- You have strong analytical skills and are attentive to detail.
- You have experience reviewing technical reports.
- You have clear communication skills (both written and oral) and are able to resolve conflicts or gain consensus.
- You have demonstrated ability to complete assignments independently.
Required skills to have for the success of this role
- You have a BA/BS in Science, Engineering or related discipline.
- You have 3-6 years of experience with FDA regulations, worldwide regulatory requirements and design control requirements for medical devices.
- You have experience with FDA regulations and design control requirements for medical devices with preference for IVDs.
- You have experience in a laboratory environment.
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.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
Equal Employment Opportunity Statement
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