Business Unit: Diagnostic Imaging
Requisition Number: 248142
Primary Location: United States-Tennessee-Knoxville
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%
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 Technical Specialist 2
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Regulatory Technical Specialist 2, you will be responsible for:
- You will be responsible for supporting the compilation, submission and maintenance of 510(k) pre-market notifications and international regulatory filings.
- You will coordinate worldwide product licensing activities including the gathering of data and the submission of registration documents to in-country Siemens Regulatory Representatives
- You will support the review of promotional material to ensure they are compliant with the product regulatory clearances/approvals
- You will stay current on global regulatory requirements and will be engaged in the implementation of new regulations
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
- You have demonstrated a working knowledge of FDA 510(k) pre-market notification requirements through successful submissions
- You have a basic understanding of EU medical device requirements (MDD and MDR)
- You have a general understanding of Quality System Requirements (FDA QSR and ISO 13485)
- You have a working knowledge of the medical device regulations in China, Canada and Japan
- You thrive in a fast paced environment while having a flexible workstyle
- You have good communication and presentation skills
Required skills to have for the success of this role
- Bachelor’s degree
- Minimum 2-5 years of regulatory experience in the medical device industry
- Ability to travel up to 15%
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:.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.