Regulatory Affairs Professional Medical Device (Remote based)

Job Description

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.

Please note that the preference is to have this role based in Hoffman Estates, IL or Knoxville, TN but will consider remote/home based for the right candidate.

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:

  • You will be responsible for the compilation, submission and maintenance of 510(k) pre-market notifications and international regulatory filings.
  • You will serve as the Regulatory representative in project development  teams to develop a global regulatory strategy to ensure timely market access of new products
  • 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 ensure promotional material 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 an excellent working knowledge of FDA 510(k) pre-market notification requirements through successful submissions
  • You have an in-depth 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 3+ years of regulatory experience in the medical device industry
  • Ability to travel 5-10%

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:

1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR

2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.

(Note: Accommodations may be requested for certain medical or religious reasons)

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

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.



Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Experienced Professional

Job Type: Full-time

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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