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Regulatory Affairs Professional

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.

Join our team now at Siemens Healthineers as a Regulatory Affairs Professional (06 S40)

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:

  • Developing and executing regulatory strategies for assigned projects to successfully register IVDs in U.S., EU, Japan, China and worldwide.  
  • Performing due diligence on 3rd party products to support Alliance Applications.
  • Reviewing and approving product labeling, advertising/promotional material, verification plans and reports. 
  • Participating in internal and external audits (as auditee and audit support).
  • Reviewing new regulations or guidance documents and assessing 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 Healthineers

  • You can multi-task, work effectively in a dynamic environment and attentive to detail.
  • You have experience building consensus, presenting convincing arguments and overcoming objections. 
  • You have a strong scientific background and understand how changes could impact assay performance.
  • You have authored regulatory submissions and successfully obtained approvals.
  • You have clear communication skills (both written and oral) and strong presentation skills.
  • You have demonstrated ability to complete assignments independently.
  • You have strong PC skills (MS Office applications, Adobe, Outlook,  OneNote, SAP).

Required skills to have for the success of this role

  • You have a BA/BS in Science, Engineering or related discipline.
  • You have 7-10 years of experience with FDA and EU regulations, design control requirements for medical devices with preference to IVDs.
  • You have experience in assay development or in a technical role in manufacturing.
  • 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
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.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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